Phase 1 Single-arm, Open-label, Multicenter Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer

The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).

Start Date30 Aug 2026

Sponsor / Collaborator

TerSera Therapeutics LLC

JPRN-jRCTs031260249

/ RecruitingPhase 2

A randomized study of Trastuzumab deruxtecan Against Second-line endocrine Therapy In hormone receptor-positive, HER2-low/ultralow metastatic breast cancer (TRANSITION)

Start Date29 Jun 2026

Sponsor / Collaborator-

ChiCTR2600126436

/ Not yet recruitingPhase 2

Neoadjuvant Trastuzumab and Pertuzumab Plus an Aromatase Inhibitor and Dalpiciclib in HR+/HER2+ Early Breast Cancer: A Single-Arm, Phase II Study

Start Date10 Jun 2026

Sponsor / Collaborator

Guangdong Hospital of Traditional Chinese Medicine

100 Clinical Results associated with Goserelin Acetate

100 Translational Medicine associated with Goserelin Acetate

100 Patents (Medical) associated with Goserelin Acetate

2,006

Literatures (Medical) associated with Goserelin Acetate

01 Jun 2026·Obstetric Medicine

Delivery of a healthy infant in a woman with breast cancer inadvertently treated with exemestane and goserelin during pregnancy: A case report

Article

Author: Davis, Georgina ; Hicks, Amy ; Sit, Andrea

Exemestane and goserelin combination therapy is a well-established adjuvant treatment for hormone receptor-positive breast cancer. Both medications are contraindicated during pregnancy as their safety in the pregnant population is not yet established. We report a rare case of a 40-year-old multigravida with T1N0M0 breast cancer, receiving exemestane and goserelin post bilateral mastectomy. Despite over four years of amenorrhoea on goserelin, she conceived unexpectedly, and inadvertently continued both medications until she discovered she was pregnant at 13 weeks' gestation. The pregnancy was uncomplicated. A healthy female infant was delivered via caesarean section at 40 weeks. The notable features of this case are inadvertent pregnancy despite induction of amenorrhoea, and no evidence of congenital fetal anomaly despite exposure to exemestane and goserelin until 13 weeks' gestation. Women of child-bearing age receiving adjuvant endocrine therapy for breast cancer should be counselled to use effective contraception to minimise risk of harmful effects in pregnancy.

01 Jun 2026·EUROPEAN JOURNAL OF ENDOCRINOLOGY

From concept to protocol: iterative approach of a target trial emulation on GnRH analog safety in transgender and gender diverse youth

Article

Author: Hannema, Sabine E ; den Heijer, Martin ; Twisk, Jos W R ; Schuurman, Gillian S

Abstract:

Context:

The scarcity of robust long-term safety data has contributed to increasing restrictions on the use of gonadotropin-releasing hormone analog (GnRHa) treatment in transgender and gender diverse adolescents (TGDAs) in several countries. Methodological limitations of earlier studies have led to controversy and debate, underscoring the urgent need for high-quality evidence in this field

Objective:

To present a study design using target trial emulation (TTE) to evaluate long-term safety of GnRHa treatment in TGDAs using observational data from national healthcare registries, and highlight methodological challenges.

Methods:

We applied a stepwise TTE approach, to emulate a randomized trial using real-world data. The main methodological challenges were identified as the selection of the control group and the definition of time zero. To address these, we engaged independent experts in causal inference to review the concept design and provide feedback on potential solutions.

Results and Discussion:

Expert feedback was systematically summarized and discussed. The resulting study design will select late-presenting TGDA individuals as the control group and defines time zero as the initiation of GnRHa treatment for the intervention group, with the equivalent age assigned as time zero in controls. Sensitivity analyses using alternative control groups and time zero definitions will be included to assess robustness. This approach allows for adjustment of confounders and aims to emulate the conditions of a randomized trial as closely as possible within the constraints of observational data.

Conclusion:

This discussion paper serves as a methodological example of target trial emulation with observational data to study long-term safety of GnRHa in TGDA. By transparently addressing methodological challenges and incorporating expert input, this approach offers a feasible and ethically sound alternative to RCTs, and contributes to the evidence base needed for informed clinical and policy decisions in transgender healthcare.

01 May 2026·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Sex and age disparities in goserelin safety: a global pharmacovigilance study

Article

Author: Fan, Guorong ; Wang, Shuowen ; Liu, Zizhen ; Qu, Han ; Wu, Zhenghua ; Lou, Yuefen ; Li, Zuan ; Zhao, Xin

Goserelin, a synthetic analogue of gonadotropin-releasing hormone, is widely used in breast cancer and prostate cancer. However, significant sex-based disparities exist in its therapeutic effects and safety profiles. What's more, current evidence remains insufficient to characterize age-related adverse drug event (ADEs) risks. Given these gaps, comprehensive real-world studies are required to systematically analyze ADEs in male and female patients separately. The analytical dataset was derived from the FAERS (2004 Q1-2025 Q1) and VigiBase (1987.01.01-2025.07.01) databases. Disproportionality analysis was performed using the reporting odds ratio and information component. All statistical analyses and visualizations were conducted using Microsoft Excel 2019, R4.4.2, and GraphPad Prism. The FAERS database recorded 8,245 ADEs (2,325 female; 3,190 male), while VigiBase contained 10,524 (3,274 female; 4,941 male). Baseline clinical outcomes revealed higher mortality rates and more serious reports in males. System organ class analysis demonstrated that males showed greater susceptibility to general disorders and administration site conditions. Several strong signals in the preferred term level not currently listed in the drug label were identified, including neutropenia, jaundice, and pleural effusion. Age-stratified analysis indicated ADEs predominantly occurred in males aged 65-74 years and females aged 40-54 years. The most frequently reported events, hot flush and interstitial lung disease, displayed stronger associations in male patients. Using real-world pharmacovigilance data, we identify sex- and age-related safety disparities for goserelin, supporting individualized monitoring and risk management to enhance treatment safety.

116

News (Medical) associated with Goserelin Acetate

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

23 Jul 2026

·www.astrazeneca.com

Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1st-line advanced ER-positive breast cancer

AstraZeneca’s Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during 1st-line endocrine therapy in combination with a CDK4/6 inhibitor. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on the positive results from the pivotal SERENA-6 Phase III trial published in The New England Journal of Medicine.1 In a planned interim analysis, the Etcamah combination reduced the risk of disease progression or death by 56% versus standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI]:0.31-0.60; p<0.00001; median progression-free survival (PFS) 16.0 versus 9.2 months). In Europe, breast cancer remains the leading cause of cancer death among women, with more than 140,000 deaths in 2024 and more than 540,000 patients diagnosed in the same year.2 Hormone receptor (HR)-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.3 More than 97% of HR-positive breast cancer tumours are ER-positive.4,5 Across the UK, France, Germany, Spain and Italy, approximately 37,000 patients with HR-positive metastatic breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies paired with CDK4/6 inhibitors.6-8 However, many patients have tumours that develop resistance to these therapies, at which point treatment options are limited and survival rates are low, with only approximately 36% of patients anticipated to live beyond five years after diagnosis.3,8 Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.9,10 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.6 François-Clément Bidard MD, PhD, Professor of Medical Oncology at Institut Curie & Versailles University (Paris/Saclay) France and co-principal investigator for the trial, said: “Today’s approval is welcome news for the one in three patients in Europe with this form of advanced breast cancer whose tumours develop ESR1 mutations before disease progression and are in urgent need of new options that both delay this progression and extend the benefit of 1st-line treatments. As the first pivotal trial to demonstrate the clinical value of monitoring circulating tumour DNA in the 1st-line breast cancer setting, SERENA-6 represents a significant advance in clinical practice and it is now important to identify patients who may be able to benefit from this combination and intervene promptly before their disease progresses.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “The approval of the Etcamah combination marks an important shift in the 1st-line treatment paradigm for patients with ER-positive, HER2-negative advanced breast cancer in Europe, providing a new standard-of-care to address emerging resistance ahead of disease progression. It also reflects the strength of AstraZeneca’s oncology pipeline and our commitment to translate innovative science into practice-changing treatment options for patients.” Data for the key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of the interim analysis of the SERENA-6 trial, however, a subsequent pre-planned analysis demonstrated a statistically significant and clinically meaningful PFS2 benefit of 25.7 months versus 19.1 months in favour of the Etcamah combination (HR: 0.63; 95% CI: 0.46-0.86; p=0.00373) and OS continued to mature in favour of the Etcamah combination (HR: 0.87; 95% CI: 0.57-1.30). The trial will continue to assess OS as a key secondary endpoint. The safety profile of Etcamah in combination with palbociclib, ribociclib or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine. No new safety concerns were identified, and discontinuations were very low and similar in both arms.1 SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The innovative trial design used ctDNA monitoring via a blood test at the time of routine tumour scans every two to three months to identify patients for early signs of endocrine resistance via the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to Etcamah from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor. Etcamah is also approved in Japan, the United Arab Emirates and Saudi Arabia based on the SERENA-6 Phase III trial. Regulatory applications for Etcamah in this setting are currently under review in several other countries including the US where the US Food and Drug Administration recently extended the Prescription Drug User Fee Act date to review the updated results from the trial. Notes HR-positive breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.11 More than two million patients were diagnosed with breast cancer in 2024, with more than 690,000 deaths globally.11 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.3 Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.6-8 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.  SERENA-6 SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation. The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment. Etcamah Etcamah (camizestrant) is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist, administered orally, once daily. The recommended dose of Etcamah in combination with a CDK4/6 inhibitor is 75mg. Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) is approved in the EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer upon detection or emergence of ESR1 mutation and without disease progression during 1st-line endocrine therapy based on the results from the SERENA-6 trial. The broad, robust and innovative Etcamah clinical development programme, including the SERENA-4, CAMBRIA-1 and CAMBRIA-2 Phase III trials, is evaluating the safety and efficacy of Etcamah when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer. Etcamah has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in the overall trial population, including in patients with ESR1 tumour mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors. 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 (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer and are exploring 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 Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

Clinical ResultPhase 3Phase 1Drug ApprovalImmunotherapy

26 Jun 2026

·www.astrazeneca.com

AstraZeneca and Daiichi Sankyo’sDatroway (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02 Phase III trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “As one of the hardest cancers to treat, today only 15% of patients with metastatic triple-negative breast cancer survive beyond five years. This positive opinion from the CHMP marks an important step forward in bringing the potential of Datroway to transform outcomes for patients with this type of cancer in the EU.” John Tsai, MD, Global Head, R&D, Daiichi Sankyo, said: “Triple-negative breast cancer remains one of the most aggressive types of breast cancer, with limited treatment options for patients with metastatic disease who are not candidates for immunotherapy and are currently treated with traditional chemotherapy. This positive recommendation by the CHMP underscores the potential for Datroway to replace traditional chemotherapy in this setting and we look forward to working closely with the EMA to bring this new indication to patients in the EU.” In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) compared to chemotherapy as 1st-line treatment in this patient population. Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR 0.57; 95% CI 0.47-0.69; p<0.0001) as assessed by blinded independent central review (BICR). Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 62.5% compared to an ORR of 29.3% with chemotherapy.1 The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer. Datroway was approved in the US in May 2026 for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Additional reviews are underway in China and Japan, as well as Australia, Canada, Singapore and Switzerland as part of Project Orbis. Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Notes Triple-negative breast cancer TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.2,3 In Europe, there are an estimated 83,000 diagnoses of TNBC each year.2,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5-7 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.5,8,9 While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.5 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.5 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.10,11However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, prior to the approval of Datroway, chemotherapy was the standard 1st-line treatment.12 TROP2 is a protein broadly expressed in several solid tumours, including TNBC.13 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.14,15 TROPION-Breast02 TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases. The dual primary endpoints of TROPION-Breast02 are OS and progression-free survival (PFS) as assessed by blinded independent central review. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety. TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov. Datroway Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Datroway is also approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial. Datroway is approved in the US for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial. Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway clinical development programme A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu (trastuzumab deruxtecan) 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. 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 (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP2-directed ADC, Datroway, 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 camizestrant 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 Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

Phase 3ImmunotherapyClinical ResultDrug Approval

100 Deals associated with Goserelin Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D00573	Goserelin Acetate	L02AE03	DB00014

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Estrogen receptor positive breast cancer	Canada	TerSera Therapeutics LLC	07 May 2024
Metrorrhagia	United States	TerSera Therapeutics LLC	27 Jul 1998
Uterine Hemorrhage	United States	TerSera Therapeutics LLC	27 Jun 1997
Premenopausal breast cancer	Japan	AstraZeneca PLC	28 Jun 1991
Breast Cancer	United States	TerSera Therapeutics LLC	29 Dec 1989
Endometriosis	United States	TerSera Therapeutics LLC	29 Dec 1989
Prostatic Cancer	United States	TerSera Therapeutics LLC	29 Dec 1989

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	China	AstraZeneca PLC	31 Mar 2020
Adenocarcinoma of prostate	Phase 3	China	Shandong Luye Pharmaceutical Co., Ltd.	06 Jan 2020
Advanced Prostate Carcinoma	Phase 3	Czechia	Acino Supply AG	06 Feb 2012
Recurrent Prostate Carcinoma	Phase 3	Canada	AstraZeneca PLC	01 Apr 2007
Early Stage Breast Carcinoma	Phase 3	-	AstraZeneca PLC	01 Dec 1990
Advanced breast cancer	Phase 2	Czechia	AstraZeneca PLC	01 Apr 2006
Advanced breast cancer	Phase 2	Russia	AstraZeneca PLC	01 Apr 2006
Advanced breast cancer	Phase 2	Ukraine	AstraZeneca PLC	01 Apr 2006
Locally advanced breast cancer	Phase 2	France	AstraZeneca PLC	01 Dec 2001
Hormone Receptor Positive Breast Adenocarcinoma	Phase 2	United States	AstraZeneca PLC	01 Oct 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02789878 (NeoPRO, ASCO2026)	Phase 2	Localized Prostate Carcinoma Neoadjuvant	62	goserelin+abiraterone acetate+prednisone	abnrvzdjdh(ngqpihzadc) = mjvhcspgzr ssrurkygwe (jzvqtwhved ) View more	Negative	29 May 2026
				goserelin+abiraterone acetate+prednisone+apalutamide	abnrvzdjdh(ngqpihzadc) = drylhkyole ssrurkygwe (jzvqtwhved ) View more
ESMO_BC2026	Not Applicable	Hormone receptor positive breast cancer HR+/HER2-	50	Goserelin 3.6 mg every 4 weeks	lunozunghp(xwoykohxqs) = hot flushes occurred in 20% vs. 44% (p = 0.069) hcmgsqsfrr (jvqzbwnvfe ) View more	Positive	07 May 2026
				Goserelin 10.8 mg every 12 weeks
NCT03361735 (CTgov)	Phase 2	Castration-sensitive prostate cancer \| Metastatic Prostate Carcinoma \| Adenocarcinoma of prostate	25	Radium Ra 223 Dichloride (De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride))	movkuorspc(kknbqokyic) = jzxdfcohhd nfbsxvitkv (jvcmiwtojo, wzmhkpodiy - nexveccvwq) View more	-	09 Apr 2026
				Radium Ra 223 Dichloride (Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride))	movkuorspc(kknbqokyic) = zetstkhbbr nfbsxvitkv (jvcmiwtojo, aqllthuffp - fpdyghglzx) View more
NCT05607004 (EVANGELINE, SABCS2025) Manual	Phase 2	ER-positive/HER2-negative Breast Cancer Neoadjuvant Estrogen receptor positive \| HER2 Negative	22	(Z)-endoxifen (40mg vs 80mg) ± Goserelin (Part 1 (PK Run-in))	crjwiomfop(oeiwfafadt) = avflllioud trefyshxax (lkrbcqkgss )	Positive	09 Dec 2025
NCT05184257 (J Natl Cancer Cent) Manual	Not Applicable	Hormone receptor positive breast cancer HR Positive	1,060	Goserelin 10.8-mg	agxafrrhxd(bjamnecsac) = dtumsfctqy rrlbktlavs (nizachmfjk, 96.9 - 99.8)	Non-inferior	01 Aug 2025
				Goserelin 3.6-mg	agxafrrhxd(bjamnecsac) = rosabneidr rrlbktlavs (nizachmfjk, 91.0 - 97.6)
Pubmed \| EJNMMI Res	Phase 2	Salivary duct carcinoma prostate-specific membrane antigen (PSMA) \| androgen receptor (AR)	8	Goserelin plus bicalutamide	zbxvhvzidn(yzkfniiqtx) = The FDG SUVmax increased in 35 lesions (44%), remained stable in 39 lesions (49%), and decreased in 6 lesions (8%), with a significant overall median increase of + 0.97 (Wilcoxon signed rank test, p < 0.001). xeujjsrdtu (ohphtlmpxi ) View more	Positive	15 Jul 2025
NCT02278120 (MONALEESA-7, ESMO_ASIA2024)	Phase 3	Hormone receptor positive breast cancer	672	Ribociclib+Endocrine Therapy	zsmppnwxtp(ptzguxiztm) = zqetknziwf xioizzzwsk (erbklsjbii )	Positive	07 Dec 2024
				Placebo+Endocrine Therapy	zsmppnwxtp(ptzguxiztm) = jjkqsvojhh xioizzzwsk (erbklsjbii )
ESMO_BC 12024 \| ESMO_BC 22024 Manual	Not Applicable	Hormone receptor positive breast cancer	590	Goserelin 10.8 mg	wxkdvrplvy(pstkdbhnct) = lqlsmiwqza ijjrsozowc (qbkfkneucb, 96.9 - 99.8)	Non-inferior	15 May 2024
				Goserelin 3.6 mg	wxkdvrplvy(pstkdbhnct) = ptcvwhnwqv ijjrsozowc (qbkfkneucb, 91.0 - 97.6)
NCT03822468 (AMALEE, CTgov)	Phase 2	Advanced cancer \| Hormone receptor positive HER2 negative breast cancer	376	Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 400 mg)	jtpivzgibt = svkfurizqu qqgadixofk (qwjrblovhb, npncxghcpt - jhjyqlxwkl) View more	-	05 Apr 2024
				Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 600 mg)	jtpivzgibt = omgthybwpy qqgadixofk (qwjrblovhb, qiqpvhtujl - xqhgrdahje) View more
NCT00295646 (ABCSG-12, CTgov)	Phase 3	Hormone receptor positive breast cancer	1,803	zoledronic acid+goserelin+anastrozole (AZ (Arimidex+Zoledronate))	bdpsykkqda(mbaygvwobz) = tschclmkss jryglvtiyw (zquczirenx, sxoloxlqvu - yiaugxbxnd) View more	-	15 Mar 2024
				tamoxifen+zoledronic acid+goserelin (TZ (Tamoxifen+Zoledronate))	bdpsykkqda(mbaygvwobz) = kfqhomrbzm jryglvtiyw (zquczirenx, vebzykyzyh - oavqkgnrmu) View more

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