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Last update 31 Jul 2026

Pertuzumab

Last update 31 Jul 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

2C4 Antibody, Anti-2C4 monoclonal antibody, Monoclonal Antibody 2C4

+ [15]

Target

HER2

Action

antagonists

Mechanism

HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [7]

Active Indication

HER2 Positive Colorectal CancerEarly Stage Breast CarcinomaBreast Cancer+ [28]

Inactive Indication

Adrenal Gland NeoplasmsAdvanced breast cancerAdvanced Lung Non-Small Cell Carcinoma+ [34]

Originator Organization

Genentech, Inc.

Active Organization

Hoffmann-La Roche, Inc.

Roche Diagnostics GmbH

Roche China Holding Ltd.

+ [8]

Inactive Organization

Roche Holding AG

Celgene Corp.

Novartis Pharmaceuticals Corp.

+ [3]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (08 Jun 2012),

Breast CancerHER2 Positive Breast CancerMetastatic breast cancer

RegulationAccelerated Approval (United States), Orphan Drug (United States)

Structure/Sequence

Sequence Code 18492L

Source: *****

Sequence Code 18505H

Source: *****

354

Clinical Trials associated with Pertuzumab

NCT07578116

/ Not yet recruitingPhase 3IIT

Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

Start Date09 Mar 2027

Sponsor / Collaborator

SWOG

[+1]

NCT07679269

/ Not yet recruitingPhase 2

An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Start Date01 Jan 2027

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07683754

/ Not yet recruitingPhase 3

A Global, Interventional, Open-label Trial of T-DXd-based Therapy Followed by Palbociclib, Endocrine Therapy and Dual HER2 Blockade in First-line HER2+/ HR+ Advanced or Metastatic Breast Cancer and Retreatment With T-DXd (DB-Guide)

This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.

Start Date04 Sep 2026

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

[+1]

100 Clinical Results associated with Pertuzumab

100 Translational Medicine associated with Pertuzumab

100 Patents (Medical) associated with Pertuzumab

1,823

Literatures (Medical) associated with Pertuzumab

01 Oct 2026·BREAST

HER2DX genomic assay in HER2-positive early breast cancer treated with trastuzumab and pertuzumab: A correlative analysis from a real-world cohort

Article

Author: Nieves, Paula Saavedra ; López, Ángel Concha ; Prat, Aleix ; Rendo, Cristina Reboredo ; Brasó-Maristany, Fara ; López, Eva Pérez ; de Castro, Beatriz Alonso ; Novoa, Silvia Antolín ; Sanfeliu, Esther ; Castillo, Oleguer ; Pena, María Alonso ; Cobo, Sandra ; Martínez, Lourdes Calvo ; Malillos, Julia Pérez ; Aguirre, Angela ; Sirenko, Valeria ; Galván, Patricia ; Blasco, Paula

BACKGROUND:

HER2DX genomic assay is a genomic tool developed for personalizing care in early-stage HER2-positive breast cancer. This real-world analysis examines its associations with pathological complete response (pCR) and invasive disease-free survival (IDFS) following trastuzumab- and pertuzumab-based neoadjuvant therapy.

MATERIALS AND METHODS:

Retrospective, observational, single-center study of 156 patients with stage I-III HER2-positive breast cancer treated with dual HER2 blockade-based neoadjuvant therapy between February 2015 and May 2022 at University Hospital A Coruña. HER2DX and clinicopathological variables were assessed in pretreatment tumor biopsies. Statistical analyses included Fisher's exact test, logistic regression, Cox proportional hazards models, and Kaplan-Meier estimates.

RESULTS:

HER2DX was performed in 111 tumors (71.2%). Overall pCR rate was 51.3%. Hormone receptor-positive disease was significantly associated with lower pCR (odds ratio [OR] 0.25, 95% CI 0.11-0.50; p < 0.001), whereas HER2 immunohistochemistry 3+ showed a non-significant trend toward higher pCR (OR 2.95, 95% CI 0.96-11.08; p = 0.075). Median IDFS was not reached, but hormone receptor-positive tumors showed better outcomes (hazard ratio [HR] 3.67, 95% CI 1.02-13.32; p = 0.004 by log-rank). The association between HER2DX pCR score and pCR appeared heterogeneous. The continuous score was significantly associated with pCR in univariable analysis, not in multivariable model. In contrast, medium-high HER2DX pCR category showed significantly higher pCR rates than low category (OR 4.83, 95% CI 1.72-14.65; p = 0.004). The continuous HER2DX risk score was independently associated with IDFS (HR 2.84, 95% CI 1.24-6.48; p = 0.010).

CONCLUSIONS:

In this cohort, HER2DX scores were associated with pCR and IDFS, supporting previous evidence and highlighting potential role in treatment stratification.

01 Aug 2026·BREAST

Tucatinib in patients with HER2-positive advanced/metastatic breast cancer: A systematic literature review of real-world evidence

Review

Author: Blahna, Matthew T ; Harbeck, Nadia ; Müller, Volkmar ; Simon, Sofia ; Gligorov, Joseph ; Anders, Carey ; Zanucco, Emanuele ; Duhoux, Francois P ; LeVasseur, Nathalie ; Criscitiello, Carmen ; Neuberger, Edward ; Bartsch, Rupert ; Lambertini, Matteo ; Foukakis, Theodoros ; Frenel, Jean-Sebastien ; Kaufman, Peter A ; Penault-Llorca, Frédérique ; Okines, Alicia ; Cameron, David A ; Rosé, Christian ; Sanchez-Bayona, Rodrigo ; Curigliano, Giuseppe ; Ciruelos, Eva M

BACKGROUND:

Recent years have seen rapid advances in human epidermal growth factor receptor 2 (HER2)-directed therapies for breast cancer. The shifting therapeutic landscape has presented patients and clinicians with a plethora of effective treatment options, but optimal treatment sequencing can be challenging. Tucatinib is a HER2-selective tyrosine kinase inhibitor that, when given in combination with trastuzumab and capecitabine, has demonstrated survival benefits for patients with HER2-positive (HER2+) metastatic breast cancer (MBC) pretreated with trastuzumab, pertuzumab, and trastuzumab-emtansine. Real-world data, which can supplement knowledge gained from clinical trials, has begun to emerge for tucatinib, but a comprehensive review of these studies has yet to be conducted.

METHODS:

A systematic literature review was conducted to identify studies published between January 2020 and January 2025 that evaluated the effectiveness and safety of tucatinib in routine clinical practice. Studies were eligible for inclusion if they utilized real-world data, involved patients with HER2+ MBC treated with tucatinib in any line of metastatic therapy, and assessed tucatinib's effectiveness, health-related quality of life (QoL), patient-reported outcomes (PROs), or safety.

RESULTS:

Of 468 unique references identified, 12 publications met the inclusion criteria, 3 of which were manuscripts and 9 of which were congress abstracts. Included studies were heterogeneous in sample size, the lines of therapy assessed, and outcomes reported. Tucatinib-based treatment outcomes in the post-trastuzumab deruxtecan (T-DXd) setting and for patients with brain metastases were also reported. Despite variability among studies, outcomes were broadly consistent with clinical trial findings.

CONCLUSION:

Overall, the available real-world evidence supports the clinical effectiveness of tucatinib-based therapies in HER2+ MBC, including heavily pretreated populations, patients with prior exposure to T-DXd, and those with brain metastases. However, gaps remain in the real-world data regarding the safety profile of tucatinib and its impact on health-related quality of life in routine clinical practice.

01 Aug 2026·NEOPLASIA

Cancer-associated fibroblast-derived protein S100-A11 influences the response to anti-HER2 therapies in HER2-positive breast cancer

Article

Author: Sanz-Álvarez, Marta ; Qin, Mengjuan ; Rovira, Ana ; Rangel, Yamileth ; Rojo, Federico ; Arguiñano, Claudia ; Luque, Melani ; Madoz-Gúrpide, Juan ; Albanell, Joan ; Morales-Gallego, Miriam ; Ramírez-Merino, Natalia

Breast cancer is the most commonly diagnosed cancer worldwide and includes the HER2-positive (HER2+) subtype, characterised by HER2 overexpression. HER2+ breast cancer is treated with neoadjuvant anti-HER2 therapy combined with taxane-based chemotherapy, yet a substantial proportion of patients fail to achieve pathological complete response. Increasing evidence indicates that the tumour microenvironment (TME), particularly cancer-associated fibroblasts (CAFs), contributes to therapy resistance through paracrine signalling. In this study, we investigated the role of stromal/CAF-derived S100-A11 in the response to trastuzumab, pertuzumab, and docetaxel (TPD) therapy. Proteomic analysis and ELISA confirmed increased S100-A11 secretion by TPD-treated CAF-200 fibroblasts. Recombinant S100-A11 reduced sensitivity to TPD in multiple HER2+ breast cancer cell lines, whereas S100A11 silencing in CAF-200 attenuated the resistance-promoting effect of CAF-conditioned medium in BT-474 and EFM-192A cells. Mechanistically, S100-A11 exposure was associated with increased STAT3 phosphorylation, and pharmacological inhibition of STAT3 or RAGE partially reversed the S100-A11-associated resistance phenotype. In a reductionist xenograft model, RAGE inhibition with azeliragon attenuated the effect of exogenous S100-A11 on tumour response to TPD. In a retrospective cohort of early-stage HER2+ breast cancer, high stromal S100-A11 expression was associated with residual disease after neoadjuvant therapy and with increased tumour p-STAT3 levels. Dual staining for S100-A11 and α-SMA further supported the presence of S100-A11-expressing CAFs in patient tumours. Together, these findings support a role for stromal S100-A11 in modulating response to anti-HER2 therapy and suggest that the S100-A11/RAGE/STAT3 axis may represent a therapeutically relevant stromal signalling pathway. Further validation in independent clinical cohorts and more physiologically representative models is required. TRANSLATIONAL RELEVANCE: Resistance to anti-HER2 therapies remains a major clinical challenge in the treatment of HER2+ breast cancer. This study identifies the stromal protein S100-A11, secreted by CAFs, as a candidate mediator associated with reduced sensitivity to TPD therapy. We show that extracellular S100-A11 promotes tumour cell proliferation and is associated with activation of the RAGE/STAT3 signalling axis. Pharmacological inhibition of this pathway using azeliragon (a RAGE antagonist) or stattic (a STAT3 inhibitor) partially reverses the S100-A11-associated resistance phenotype in vitro and in a reductionist xenograft model. In parallel, high stromal S100-A11 expression is associated with poorer pathological response in a retrospective cohort of early-stage HER2+ breast cancer patients. While these findings are exploratory, they support the potential relevance of stromal S100-A11 as a component of the TME linked to therapy response. Overall, this work provides a rationale for further investigation of the S100-A11/RAGE/STAT3 axis as a potential target in stromal-mediated resistance to anti-HER2 therapy. CONCEPTUAL ADVANCE: This study provides further insight into the mechanisms underlying resistance to anti-HER2 therapy by identifying a therapy-associated, stroma-related adaptive response that may contribute to reduced treatment sensitivity beyond tumour-intrinsic alterations. While resistance in HER2+ breast cancer has traditionally been attributed to oncogenic signalling rewiring within tumour cells, our findings suggest that anti-HER2 therapy may also influence CAFs, promoting the secretion of factors that support tumour cell survival under therapeutic pressure. In this context, we describe a paracrine signalling interaction in which CAF-associated S100-A11 is linked to activation of the RAGE/STAT3 axis in tumour cells, accompanied by increased proliferation and reduced sensitivity to treatment. These observations support a model in which the TME acts as an active contributor to adaptive resistance, rather than a passive component. Moreover, the partial reversibility of this phenotype through pharmacological inhibition of RAGE or STAT3 suggests that stromal signalling pathways may represent potential targets for therapeutic intervention. Overall, these findings expand current perspectives on resistance by incorporating the contribution of therapy-associated stromal responses and support further investigation into combinatorial strategies targeting both tumour cells and their TME.

319

News (Medical) associated with Pertuzumab

28 Jul 2026

·www.biospace.com

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 phase 3 trial presented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (hazard ratio: 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients (n=383) with HER2 positive metastatic breast cancer who had not received prior chemotherapy or HER2 targeted therapy or had received neoadjuvant or adjuvant HER2 targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months (95% CI: 36.5-not estimable [NE]) with Enhertu in combination with pertuzumab compared to 26.9 months (95% CI: 21.8-NE) with THP as assessed by blinded independent central review (BICR). The PFS benefit was consistent across subgroups, including the prespecified stratification factors of hormone receptor (HR) status, de novo or recurrent disease and PIK3CA mutation status. Confirmed objective response rate (ORR) was 85.1% (95% CI: 81.2-88.5) for Enhertu in combination with pertuzumab compared to 78.6% (95% CI: 74.1-82.5) with THP. There were 58 (15.1%) complete responses (CR) and 268 (70.0%) partial responses (PR) with Enhertu plus pertuzumab compared to 33 (8.5%) CRs and 271 (70.0%) PRs with THP. Median duration of response (DOR) for Enhertu plus pertuzumab exceeded three years (39.2 months) versus 26.4 months for THP. “Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2 positive disease,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2 positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.” “HER2 positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2 targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2 positive metastatic breast cancer.” The safety pro Enhertu in combination with pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual treatment with no new safety concerns identified. The most common grade 3 or higher treatment-related adverse events that occurred in patients treated with Enhertu in combination with pertuzumab (n=381) were neutropenia (23.9%), hypokalemia (10.2%), and anemia (8.4%). Interstitial lung disease (ILD) or pneumonitis occurred in 12.1% of patients treated with Enhertu in combination with pertuzumab as determined by an independent adjudication committee. The majority of ILD or pneumonitis events were low grade (grade 1 [n=17; 4.5% or grade 2 [n=27; 7.1%]). There were two grade 5 events (0.5%) of ILD or pneumonitis in the Enhertu plus pertuzumab arm. Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in India, Israel, Saudi Arabia, Singapore, South Korea, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu is also under review in the EU for patients with HER2 positive breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment based on data from the DESTINY-Breast05 trial. DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer. Patients were randomized 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), HR status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, DOR, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related deaths among women. Approximately 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.1 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.2 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.3 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.4 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer is considered HER2 positive.5 HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.5 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.6,7,8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.9,10 Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4 mg/kg) followed by THP is approved in China, Singapore and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (5.4 mg/kg) is approved in the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in India, Israel, Saudi Arabia, Singapore, South Korea, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. Enhertu (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. A comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers. Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu in March 2019 and Datroway ® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. REFERENCES: 1 World Health Organization. Global Status Report On Cancer 2026: The Future We Choose Together. Accessed July 2026. 2 World Health Organization. Breast Fact Sheet. Accessed July 2026. 3 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed July 2026. 4 Cheng X. Genes(Basel). 2024;15(7):903. 5 Tarantino P, et al.Ann Oncol. 2023;34(8):645-659. 6 Swain SM, et al. Lancet Oncol. 2020;21(4):519-530. 7 Blumenthal G, et al. Clin Cancer Res. 2013;19(18):4911-4916. 8 Tripathy D, et al. Oncologist. 2020;25(2):e214-e222. 9 Hall PS, et al. Presented at SABCS Annual Meeting 2023. 10 Hartkopf AD, et al. Geburtshilfe Frauenheilkd. 2024;84(5):459-469. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalASCOLicense out/in

24 Jul 2026

·firstwordpharma.com

EU panel endorses label upgrades for Trodelvy, Enhertu in 1L breast cancer

A pair of antibody-drug conjugate (ADC)-based breast cancer regimens are a step closer to European approval for some first-line indications.Gilead Sciences' Trodelvy (sacituzumab govitecan) secured its second first-line metastatic triple-negative breast cancer (TNBC) endorsement in Europe in the span of a month, with the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the TROP2-directed ADC together with Merck & Co.'s Keytruda (pembrolizumab) for patients whose tumours express PD-L1."If authorised, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status," said Evandro de Azambuja, investigator of the Phase III ASCENT-04/KEYNOTE-D19 study backing the latest recommendation.EU regulators had approved Trodelvy as a single agent last month in the frontline setting for metastatic TNBC based on data from the Phase III ASCENT-03 study, where it showed a 38% reduced risk of disease progression or death in patients who aren't candidates for PD-(L)1 inhibitors.In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% lower risk of disease progression or death in patients with PD-L1–positive metastatic TNBC. In more recent data presented at this year's American Society of Clinical Oncology (ASCO) meeting, the Trodelvy-Keytruda combo led to a 33% reduction in the risk of a progression-free survival 2 (PFS2) event versus Keytruda plus chemotherapy (see – KOL Views Q&A: Breast cancer at ASCO – first take on AZ and Roche oral SERD debates, Gilead's Trodelvy TNBC data and KOL Views Q&A: Gilead’s Trodelvy poised to redefine ADC sequencing in TNBC).A nod for EnhertuCHMP also adopted a positive opinion for AstraZeneca and Daiichi Sankyo's HER2-targeting ADC Enhertu (trastuzumab deruxtecan) in combination with Roche's Perjeta (pertuzumab) as a first-line treatment for HER2-positive metastatic breast cancer.The endorsement was backed by Phase III results from the DESTINY-Breast09 trial, where Enhertu-treated patients had a 44% lower risk of disease progression or death versus the current standard of taxane, Herceptin (trastuzumab) and Perjeta. Median PFS stood at 40.7 months for the doublet and 26.9 months for the comparator group.If approved, the regimen would become the first new first-line treatment option for HER2-positive metastatic breast cancer in the EU in more than a decade, according to AstraZeneca. The regimen was greenlit in this setting by the FDA late last year.

Clinical ResultPhase 3ASCODrug ApprovalADC

24 Jul 2026

·www.astrazeneca.com

Enhertu plus pertuzumab recommended for approval in the EU by CHMP as 1st-line treatment for patients with HER2-positive metastatic breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 Phase III trial presented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine.1 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “HER2-positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2-targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes. DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2-positive metastatic breast cancer.” John Tsai, Global Head, R&D, Daiichi Sankyo, said: “Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2-positive disease. Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2-positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.” In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP. The PFS benefit was consistent across subgroups, including for the prespecified stratification factorsof hormone receptor status, de novo or recurrent disease and PIK3CA mutation status. The safety profile of Enhertu plus pertuzumab was consistent with the known profiles of each individual therapy with no new safety concerns identified. Enhertu in combination with pertuzumab is approved in the US, Switzerland and other countries as a 1st-line treatment for patients with metastatic HER2-positive breast cancer based on the results from the DESTINY-Breast09 trial. Enhertu is also under review in the EU for patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 trial. Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Notes HER2-positive metastatic breast cancer Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related death among women.2 Approximately, 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.2 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.3 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.4 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer is considered HER2-positive.5 HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.6 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.6-8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.10,11 DESTINY-Breast09 DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, duration of response, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov. Enhertu Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4mg/kg) followed by THP is approved in the US, China and Singapore as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (5.4mg/kg) is approved in the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, India, Israel, United Arab Emirates, Saudi Arabia, Korea and Singapore as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial. Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorised test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. Enhertu (5.4mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu clinical development programme A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and expanding its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD, Etcamah. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with Etcamah in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Oncology Corporate and financial

Clinical ResultDrug ApprovalPhase 3License out/inASCO

100 Deals associated with Pertuzumab

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KEGG	Wiki	ATC	Drug Bank
D05446	Pertuzumab	L01XC13	DB06366

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Early Stage Breast Carcinoma	Australia	Roche Products Pty Ltd.	06 May 2013
Breast Cancer	United States	Genentech, Inc.	08 Jun 2012
HER2 Positive Breast Cancer	United States	Genentech, Inc.	08 Jun 2012
Metastatic breast cancer	United States	Genentech, Inc.	08 Jun 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02252887 (CTgov)	Phase 2	Advanced HER2-Positive Breast Carcinoma \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	45	Trastuzumab+Gemcitabine+Pertuzumab	ahefidwdrp = hnnhpenemz suqndxdwpy (wtfjdxfdmy, ednorpluuy - brphipodgf) View more	-	24 Jul 2026
NCT03716180 (DAPHNe, Pubmed \| JAMA Oncol)	Phase 2	Neoadjuvant ERBB2-positive	98	Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab (THP) (Stage II to III ERBB2-Positive Breast Cancer)	phphqdolgg(rroitlqhhk) = yolpzblwyx ouqgrmtarm (btkabktiev, 97 - 100) View more	Positive	25 Jun 2026
NCT04858529 (neoCARHP, Pubmed \| J Clin Oncol)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	766	Taxane + Trastuzumab + Pertuzumab + Carboplatin	zesrmtwjtp(ywunxdkxch) = vbsyrksbpp htusthczgz (pavaebagqo, 60.9 - 70.6) View more	Positive	10 Jun 2026
				Taxane + Trastuzumab + Pertuzumab	zesrmtwjtp(ywunxdkxch) = pplwphfyel htusthczgz (pavaebagqo, 59.1 - 69.0) View more
ASCO2026	Not Applicable	Metastatic breast cancer HR+/HER2+	957	Dual HER2 blockade + ET without induction	gsalfxomun(pddnrbtaru) = hhrutfzahj zishosmxkx (cayrmfmjni ) View more	Positive	29 May 2026
				Dual HER2 blockade + ET with taxane induction	gsalfxomun(pddnrbtaru) = wqagumhjvs zishosmxkx (cayrmfmjni ) View more
ASCO2026	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	219	Biosimilar Pertuzumab with Trastuzumab	yqdlpldwcz(utdwsqjzdy) = No significant adverse events reported other than diarrhoea. None of them had treatment discontinuation due to cardiac toxicity. fojxvzncpe (qzximdskfp )	Positive	29 May 2026
				Phesgo (Pertuzumab/Trastuzumab/Hyaluronidase)
ChiCTR2500109920 (TORCH, ASCO2026)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	18	toripalimab+inetetamab+Pertuzumab+nab-paclitaxel	praehaseyk(trnihnzqdb) = qgryguluxj cpnzrtccxl (ksnzqdsrlb ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2-positive	128	Adjuvant Trastuzumab	oxkbynoknr(ohkhsjzdac) = fgrvfzbmtq alkinibnwe (vvqpdozyyb ) View more	Positive	29 May 2026
				Adjuvant Trastuzumab and Pertuzumab	oxkbynoknr(ohkhsjzdac) = xhfzeqxfgc alkinibnwe (vvqpdozyyb ) View more
ASCO2026	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	53	Neoadjuvant TCHP	vxvrxvmjce(znicdgngfd) = pwvadobphn dylqkqupgd (whbougdnaa, 44.1 - 71.9) View more	Positive	29 May 2026
				Neoadjuvant TCHP (HR-positive)	vxvrxvmjce(znicdgngfd) = uoltkomdjw dylqkqupgd (whbougdnaa, 32.8 - 74.4)
ASCO2026	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2-positive	87	Trastuzumab+pertuzumab	slbczvxdgj(vvzyrawdsx) = uvporxlgui astqvrslxi (osjegxcopw, 28.5) View more	Positive	29 May 2026
				Trastuzumab	xmrbtygete(ktwizonkeu) = yptcbrrgww cmremotzrw (snbyqrkevl )
NCT03272477 (WSG TP-II, Pubmed \| J Clin Oncol)	Phase 2	Hormone receptor positive HER2 positive breast cancer Neoadjuvant hormone receptor-positive \| human epidermal growth factor receptor 2 (HER2)-positive	207	Neoadjuvant paclitaxel + trastuzumab + pertuzumab	udcohoopkn(alxfjobujz) = nvedbqthzv vatkphsgxc (gxeqgmjgap, 90.5 - 99.3) View more	Positive	18 May 2026
				Neoadjuvant endocrine therapy + trastuzumab + pertuzumab	udcohoopkn(alxfjobujz) = zxyverumyx vatkphsgxc (gxeqgmjgap, 86.6 - 97.9) View more

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