This is a prospective, single-center, two-arm Phase 1 safety and feasibility trial evaluating anti-estrogen therapy in men age 50 years and older with symptomatic unilateral inguinal hernias. Participants will be randomized to receive Fulvestrant 250 mg intramuscularly or anastrozole 1 mg orally for 6 months. The study will evaluate safety, tolerability, feasibility, hormone changes, hernia size, patient-reported outcomes, bone density, and imaging-based hernia classification.

Start Date02 Oct 2026

Sponsor / Collaborator

Northwestern University

NCT07716046

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for First-line Maintenance or Upfront Chemo-Free Treatment in HR+/HER2+ Advanced Breast Cancer: A Multicenter, Open-label, Randomized Controlled Phase II Study

This phase II, multicenter, open-label, randomized controlled trial (FACET study) evaluates the efficacy and safety of fulvestaciclib, a novel oral CDK4/6 inhibitor, combined with anti-HER2 dual blockade (trastuzumab and pertuzumab, HP) and endocrine therapy (ET) in hormone receptor-positive (HR+) and HER2-positive advanced breast cancer (ABC).
Patients with HR+/HER2+ ABC without prior systemic therapy for advanced disease are randomized in a 1:1:1 ratio into three arms, stratified by visceral metastasis status (yes vs. no) and metastatic type (de novo vs. recurrent).
Arm A: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive fulvestaciclib + HP + ET as maintenance therapy.
Arm B: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive HP + ET alone (without fulvestaciclib) as maintenance therapy.
Arm C (exploratory): Patients receive upfront fulvestaciclib + HP + ET as first-line therapy without induction chemotherapy (chemo-free).
For premenopausal/perimenopausal patients, ovarian function suppression (OFS) is added in all arms. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.
The primary endpoint is investigator-assessed progression-free survival (PFS) comparing Arm A versus Arm B. Secondary endpoints include PFS (Arm A vs. Arm C), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR), cumulative incidence of central nervous system (CNS) metastases, safety, and patient-reported outcomes (PROs).

Start Date01 Oct 2026

Sponsor / Collaborator

Fudan University

[+1]

NCT07391774

/ RecruitingPhase 3IIT

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS Less Than or Equal to 25 (RxFINE-Low)

This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. 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. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.

Start Date10 Aug 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Anastrozole

100 Translational Medicine associated with Anastrozole

100 Patents (Medical) associated with Anastrozole

2,825

Literatures (Medical) associated with Anastrozole

01 Dec 2026·Case reports in women's health

Advanced vulvar adenocarcinoma of mammary gland type: a case report

Article

Author: Levin, Lane ; Reeson, Monica ; Hoekstra, Anna

Vulvar adenocarcinoma of mammary gland type (AMGT) is a rare, locally aggressive neoplasm of anogenital mammary-like glands that mimics the histologic and immunophenotypic features of breast carcinoma. Fewer than 60 cases have been described in the literature since the first documented case in 1936. The extreme rarity and resemblance to breast carcinoma complicate diagnosis and treatment. This report presents a case of AMGT in a 61-year-old woman who presented with a palpable, subcutaneous lesion of the lateral mons pubis and labia minora. Initial biopsy identified the lesion as metastatic carcinoma, but immunohistochemical (IHC) analysis and PET/CT indicated a vulvar adenocarcinoma with local nodal metastasis. Aggressive management with radical vulvectomy and bilateral inguinofemoral lymphadenectomy with thorough specimen evaluation by surgical pathology led to the final diagnosis of AMGT TNM stage pT1bpN2cM0 and vulvar FIGO Stage IIIC. IHC staining identified the tumor as ER, PR, and 3+ HER2 positive. Breast cancer treatment guidelines informed the ultimate systemic therapy regimen of docetaxel, carboplatin, trastuzumab, and pertuzumab. Maintenance therapy with trastuzumab and anastrozole was utilized. The patient remained in remission from AMGT 24 months following completion of chemotherapy. While the diagnosis of AMGT poses a unique challenge, IHC staining and imaging to rule out metastatic carcinoma can support the ultimate diagnosis. The sustained remission in this case supports the extrapolation of treatment from vulvar and breast cancer guidelines. Additionally, this case suggests the utility of hormone receptor- and HER2-targeted therapies for systemic treatment.

05 Oct 2026·Cureus Journal of Medical Science

Real-World Effectiveness, Safety, and Tolerability of Adjuvant CDK4/6 Inhibitor Therapy

Article

Author: Patel, Apurva ; Shah, Kajal ; Yadav, Rajan ; Panchal, Harsha P

BACKGROUND:

This study evaluates the real-world effectiveness, safety, and tolerability of adjuvant abemaciclib or ribociclib combined with a non-steroidal aromatase inhibitor (NSAI) in high-risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer in Western India.

METHODS:

We conducted a retrospective, single-institution study at The Gujarat Cancer and Research Institute (GCRI) in Ahmedabad, India, evaluating high-risk, stage II or III HR+/HER2- early breast cancer patients treated between November 2021 and May 2026. A total of 418 patients were evaluated across three groups: Group 1 received abemaciclib (150 mg twice daily for two years) plus NSAI (letrozole or anastrozole) (n = 138); Group 2 received ribociclib (400 mg daily, three weeks on, one week off for three years) plus NSAI (letrozole or anastrozole) (n = 138); and Group 3 received NSAI (letrozole or anastrozole) alone for ≥ 5 years (n = 142). The primary endpoint was invasive disease-free survival (iDFS), and secondary endpoints included overall survival (OS) and safety.

RESULTS:

Baseline characteristics were well-balanced across all three groups, with approximately three-quarters of the patients presenting with advanced stage III disease (77.8%, n=325/418). Adjuvant CDK4/6 inhibitor therapy significantly improved iDFS compared to NSAI alone. Abemaciclib plus NSAI (Group 1) was associated with an approximately 50% relative hazard reduction for an iDFS event compared to NSAI alone (HR 0.50; 95% CI, 0.27-0.91; p = 0.023). Ribociclib plus NSAI (Group 2) demonstrated a 48% relative hazard reduction compared to NSAI alone (HR 0.52; 95% CI, 0.29-0.93; p = 0.027). The estimated two-year iDFS rates were 93.5% (n = 129/138) in Group 1, 88.4% (n = 122/138) in Group 2, and 78.2% (n = 111/142) in Group 3. After applying a Bonferroni correction (α = 0.025), the iDFS benefit remained statistically significant for abemaciclib (p = 0.023), whereas ribociclib (p = 0.027) demonstrated a strong numerical trend that did not meet the adjusted threshold. Overall survival was not estimable due to insufficient events. Adverse events were consistent with established safety profiles: diarrhea was the most frequent adverse event in Group 1 (78.2%, n = 108/138), whereas neutropenia (63.0%, n = 87/138) and arthralgia (71.0%, n = 98/138) were prominent in Group 2. Permanent treatment discontinuation due to adverse events occurred in 13.8% (19/138) of patients in Group 1 and 13% (18/138) in Group 2.

CONCLUSION:

In this retrospective non-randomized study, adding adjuvant abemaciclib or ribociclib to NSAI therapy was associated with two-year iDFS improvements in high-risk HR+/HER2- early breast cancer. However, after Bonferroni correction, the iDFS benefit remained statistically significant for abemaciclib and did not remain statistically significant for ribociclib. The therapies proved highly feasible and manageable in routine clinical practice.

01 Oct 2026·TISSUE & CELL

Dose-dependent neurotoxic effects of anastrozole via disrupting NLRP3 inflammasome and α-synuclein pathways

Article

Author: Alkhoshaiban, Abdulaziz Saleh ; Alzahrani, Khalid J ; Alghamdi, Amani ; Alzahrani, Fuad M ; Jamil, Salim ; Hassan, Hesham M ; Azmat, Muhammad Bilal ; Alsharif, Khalaf F

Anastrozole (ANZ) is a commonly used aromatase inhibitor in the treatment of hormone-dependent breast cancer. Despite its toxicity profile reported in different studies, the neurotoxic effects against this drug have not been explored yet. The present study was aimed at investigating the neurotoxic effects of ANZ in Sprague Dawley rats using comprehensive biochemical, molecular and histopathological analysis. Rats were divided into control and ANZ treated (0.1, 0.2 and 0.5 mg/ kg) doses. It was found that ANZ intoxication promoted the gene expression of NLRP3, PYCARD, CASP1, IL1-β, IL18, TXNIP, SNCA, and LRRK2 while suppressing the expression of PARK2, PINK1, PARK7 and UCHL1 in dose dependent manner. Moreover, ANZ exposure significantly reduced the antioxidant defense systems as shown by reduction in the activities of catalase (CAT), superoxide dismutase (SOD), glutathione reductase (GSR), glutathione-peroxidase (GPx) and heme oxygenase-1 (HO-1) coupled with elevated levels of malondialdehyde (MDA) and reactive oxygen species (ROS). Similarly, ANZ administration showed marked reductions in the levels of BDNF, NGF, GDNF PSD-95, and synaptophysin while increasing the levels of NF-κB, COX-2, TNF-α, IL-1β, and IL-6. Nonetheless, ANZ exposure provoked the levels of Caspase-9, Bax, and Caspase-3 while inhibiting the levels of Bcl-2. Histological examination confirmed the dose-dependent neuronal degeneration such as vacuolization, pyknosis and structural disorganization. Collectively, these results showed that ANZ causes significant neurotoxicity due to oxidative stress, inflammation, and apoptosis resulting in neuronal survival and function dysfunction. This study shows the importance of careful therapeutic use of ANZ and laid down the foundation for further research on the neurological safety profile of ANZ.

115

News (Medical) associated with Anastrozole

22 Oct 2026

·www.biospace.com

Daiichi Sankyo Highlights Ongoing Progress Across Industry-Leading ADC Portfolio with New Research Updates at ESMO

New data from six landmark trials reinforce practice-changing results of Enhertu and Datroway across a broad spectrum of patients in breast and lung cancer Additional analyses from two trials of raludotatug deruxtecan in ovarian cancer demonstrate emerging potential in gynecological cancers TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 30 abstracts, including four late breaking presentations, in multiple cancers at the 2026 European Society for Medical Oncology (#ESMO26) Congress. New data from six landmark trials demonstrate the company’s progress toward advancing new standards of care for patients in breast and lung cancer, including the DESTINY-Breast05 ( 539RO ), DESTINY-Breast06 ( 4279P ), DESTINY-Breast09 ( LBA49 ), DESTINY-Breast11 ( 543RO ) and DESTINY-Lung04 ( LBA74 ) phase 3 trials of Enhertu ® (trastuzumab deruxtecan) and the TROPION-Breast02 ( LBA96 ) phase 3 trial of Datroway ® (datopotamab deruxtecan). Additional data at ESMO also will spotlight the company’s commitment to advancing research for patients with advanced ovarian cancer across lines of therapy. An updated analysis, including progression-free survival and duration of response, will be presented from the REJOICE-Ovarian01 ( 1331P ) phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. A mini oral presentation will highlight preliminary findings from the REJOICE-Ovarian02 ( 1247RO ) phase 1b/2 trial evaluating raludotatug deruxtecan in combination with bevacizumab in patients with platinum-resistant ovarian cancer. “The promising data for raludotatug deruxtecan in ovarian cancer and the robust scientific innovation demonstrated across our pipeline reflects our progress in advancing research for patients across multiple types of cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo continues to draw from its scientific and technological expertise to turn science into new medicines that can change the standard of care.” Data Demonstrate Benefit of DXd ADCs in Patients with Brain Metastases Research updates highlighting the impact of DXd ADCs in patients with brain metastases include late-breaking rapid oral and proffered paper presentations from the DESTINY-Breast09 ( LBA49 ) phase 3 trial evaluating Enhertu in combination with pertuzumab as a first-line treatment for patients with HER2 positive metastatic breast cancer and the TROPION-Breast02 ( LBA96 ) phase 3 trial evaluating Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option. Final overall survival results of the TUXEDO-3 ( 690O ) phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases from metastatic breast cancer, advanced non-small cell lung cancer (NSCLC) or leptomeningeal disease from any solid tumor will be presented as a proffered paper. New Data and Trials-in-Progress Presentations Across DXd ADC Portfolio Additional data highlighting new research across the DXd ADC portfolio include oral and poster presentations, including final results of the TALENT ( LBA23 ) phase 2 trial of Enhertu alone or in combination with anastrozole, or in sequence with chemotherapy, as neoadjuvant treatment for patients with HR positive, HER2 low early stage breast cancer. New data in NSCLC include the NeoCOAST-2 ( 4244RO ) phase 2 trial reporting event-free survival results, as well as findings on the association of ctDNA clearance with clinical outcomes in patients with resectable, early stage NSCLC treated with a combination of Datroway plus durvalumab and chemotherapy, and a retrospective analysis evaluating mechanisms of insensitivity to the Datroway payload in subgroups of patients with advanced NSCLC in the TROPION-Lung01 ( 4451P ) phase 3 trial. Updated findings from the EPOC2003 ( 2888P ) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer: results from ESPERANZA ( 1014P ), an external comparator study evaluating Enhertu versus real-world standard of care as a second line or later treatment for patients with HER2 IHC 3+ solid tumors; and, the primary analysis evaluating patritumab deruxtecan monotherapy in patients with melanoma in the HERTHENA-PanTumor01 ( 2073RO ) phase 2 trial also will be presented. Trials-in-progress poster presentations include the DESTINY-Breast Guide ( 1795TiP ) prospective and interventional trial evaluating first-line treatment with Enhertu plus pertuzumab followed by palbociclib, endocrine therapy and dual HER2 blockade (trastuzumab plus pertuzumab), as well as retreatment with Enhertu following progression on maintenance therapy (palbociclib, endocrine therapy and trastuzumab plus pertuzumab) in previously untreated patients with HER2 positive advanced or metastatic breast cancer and the TROY ( 1335TiP ) phase 2 trial evaluating Enhertu in patients with recurrent ovarian cancer with disease progression on prior PARP inhibitor therapy. An overview of late-breaking, clinical data and trials-in-progress presentations from the ADC portfolio of Daiichi Sankyo includes: Presentation Title Author Abstract Presentation (CEST) LBAs Final results of TALENT: a neoadjuvant trial of T-DXd with or without anastrozole, or in sequence with chemotherapy for HER2-low, HR+ early-stage breast cancer S. Hurvitz LBA23 Proffered Paper Presentation Friday, October 23 1:30 pm – 3:00 pm First-line datopotamab deruxtecan (Dato-DXd) vs. chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: exploratory analysis of patients with brain metastases in TROPION-Breast02 R. Dent LBA96 Proffered Paper Presentation Saturday, October 24 8:30 am – 10:00 am First-line trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant NSCLC: patient-reported outcomes from DESTINY-Lung04 S. Novello LBA74 Rapid Oral Presentation Saturday, October 24 8:30 am – 10:00 am DESTINY-Breast09 analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab for patients with HER2+ advanced/metastatic breast cancer and baseline brain metastases C. Saura LBA49 Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Breast DESTINY-Breast11: MRI-assessed objective responses during neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab vs. dose-dense doxorubicin + cyclophosphamide followed by THP in HER2+ early breast cancer J.F. Boileau 543RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Patient-reported outcomes from DESTINY-Breast05: health-related quality of life with trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with high-risk HER2 positive early breast cancer C. Barrios 539RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Paired-biopsy multi-omic analysis reveals target-independent mechanisms of antibody-drug conjugate resistance in metastatic breast cancer P. Tarantino 4449RO Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Trastuzumab deruxtecan (T-DXd) vs. physician’s choice of chemotherapy in HR+, HER2 low metastatic breast cancer: a DESTINY-Breast06 ctDNA molecular response analysis G. Curigliano 4279P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Trastuzumab deruxtecan (T-DXd) + pembrolizumab in previously treated human epidermal growth factor receptor 2-expressing advanced or metastatic breast cancer: primary analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106 H. Rugo 1771P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm DESTINY-Breast Respond HER2 low Europe non-interventional study of trastuzumab deruxtecan (T-DXd) in HER2 low metastatic breast cancer: update on baseline characteristics and anti-emetic treatment J.Y. Pierga 12P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Improving accuracy in HER2 ultralow identification: multi-site validation of an AI-decision support tool B. Van der Vegt 1784P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Comparative evaluation of 7 artificial intelligence tools for HER2-low and ultralow scoring in breast cancer J.S. Frenel 287P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm A global, interventional, open-label trial of trastuzumab deruxtecan (T-DXd)-based therapy followed by palbociclib, endocrine therapy, and dual HER2 blockade in first-line human epidermal growth factor receptor positive, hormone receptor-positive advanced or metastatic breast cancer and retreatment with T-DXd (DESTINY-Breast Guide) S. Sammons 1795TiP Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Lung NeoCOAST-2: association of ctDNA clearance with clinical outcomes in a global platform phase 2 perioperative trial T. Cascone 4244RO Rapid Oral Presentation Sunday, October 25 8:30 am – 10:00 am Mechanisms of insensitivity to the datopotamab deruxtecan (Dato-DXd) payload in subgroups of patients with advanced non-small cell lung cancer in TROPION Lung01 N. Girard 4451P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: IDeate-Lung01 updated results M. Ahn 3842P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Ovarian Raludotatug deruxtecan (R-DXd) + bevacizumab in participants with platinum-resistant recurrent ovarian cancer: results for cohort B-1 of the phase 1b/2 REJOICE-Ovarian02 study A. Oaknin 1247RO Rapid Oral Presentation Saturday, October 24 08:30 am – 10:00 am Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: an updated analysis of efficacy and tolerability from the phase 2 part of REJOICE-Ovarian01 K. Hasegawa 1331P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm A randomized phase 2, open-label, multicenter, study of trastuzumab deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14) J.Y. Lee 1335TiP Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Gastric Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma from DESTINY-Gastric04 M. Gumus 2925P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm Perioperative trastuzumab deruxtecan plus capecitabine and durvalumab in HER2 positive gastric or gastroesophageal junction cancer: a phase II study (EPOC2003) D. Takahari 2888P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm PanTumor Final results of the TUXEDO-3 phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases and leptomeningeal disease M. Preusser 690O Proffered Paper Presentation Sunday, October 25 10:15 am – 11:45 am Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: primary analysis from HERTHENA-PanTumor01 M. McKean 2073RO Rapid Oral Presentation Sunday, October 25 10:15 am – 11:45 am ESPERANZA: Results from an external comparator study of trastuzumab deruxtecan in HER2 IHC3+ solid tumors F. Meric-Bernstam 1014P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of nine 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. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo 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. For more information, please visit . Contacts MEDIA CONTACTS: Global: Jennifer Brennan Jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

Phase 2Phase 3Clinical ResultADCImmunotherapy

19 Oct 2026

·www.biospace.com

Havah Therapeutics Urges FDA to Recognize the Breast Cancer Treatment Potential of Androgen Receptor Activation

HAV-088 is testing this approach in the randomized Phase 2 RECAST DCIS trial BOULDER, Colo.--(BUSINESS WIRE)-- #DCIS --Havah Therapeutics, Inc. today urged the U.S. Food and Drug Administration to recognize the therapeutic potential of androgen receptor activation in estrogen receptor-positive breast cancer. Backing scientific commentary prepared by its founder, Dr. Stephen Birrell, Havah called for FDA’s evaluation of testosterone in women to reflect published oncology evidence and assess risk by cancer subtype, formulation and clinical exposure. Dr. Birrell’s commentary responds to FDA’s September 17 workshop on Testosterone Use in Menopausal Women. Public comments under docket FDA-2026-N-5479 close today. “The science has advanced, and the regulatory discussion needs to reflect it,” said Matthew Brewer, Chief Executive Officer of Havah Therapeutics. “Women need more choices in breast cancer care. With HAV-088 in Phase 2, we are testing whether androgen receptor activation can help women with DCIS control their disease and preserve their breasts.” Research published in Nature Medicine in 2021 demonstrated that androgen receptor activation suppressed tumor growth in estrogen receptor-positive breast cancer models. A 2024 Phase 2 study in The Lancet Oncology reported clinical activity with enobosarm, a different investigational androgen receptor agonist, in advanced disease. These findings support clinical development; they do not establish HAV-088’s efficacy or long-term testosterone safety. “FDA should evaluate what a specific androgen regimen does in a specific breast cancer subtype,” said Dr. Birrell. “The evidence for androgen receptor activation in estrogen receptor-positive disease warrants direct clinical investigation. We need to measure its effects in breast tissue and establish benefit and safety in patients.” Havah supports three priorities outlined by Dr. Birrell: Assess androgen effects by breast cancer subtype. Evaluate dose, formulation, delivery route and tissue activity alongside clinical outcomes. Work with data holders to publish treatment-specific breast and cardiovascular safety outcomes from the historical LibiGel BLISS trial. Advancing HAV-088 in DCIS HAV-088 combines testosterone and low-dose anastrozole in an investigational implant designed to deliver approximately three months of therapy. The approach aims to strengthen local androgen signaling: testosterone supplies a precursor for dihydrotestosterone, while low-dose anastrozole is intended to limit competing conversion to estrogen. HAV-088 is being evaluated in RECAST DCIS (NCT06075953) , a randomized Phase 2 platform sponsored by Quantum Leap Healthcare Collaborative. The trial tests whether endocrine therapy and MRI monitoring can help women with hormone receptor-positive ductal carcinoma in situ remain suitable for active surveillance. Surgery remains standard treatment. HAV-088 is not FDA-approved, and its safety and efficacy have not been established. About Havah Therapeutics Havah Therapeutics is developing a novel therapeutic implant intended to treat hormonally sensitive cancers and other breast conditions. This groundbreaking method relies on stimulating (agonizing) the androgen receptor in breast tissue, utilizing natural hormonal mechanisms to potentially treat women safely and with greatly reduced side effects. The product candidate, HAV-088, is a combination of two registered agents (testosterone and anastrozole, a low dose aromatase inhibitor) that is designed to provide three months of continuous medication, which the Company believes may enable a superior product pro compliance, safety and efficacy. Havah Therapeutics is currently participating in the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. For more information, visit . Contacts Media and Investor Contact Matthew Brewer | Chief Executive Officer Havah Therapeutics, Inc. | mb@havahtx.com

Phase 2

18 Sep 2026

·firstwordpharma.com

FDA widens Inluriyo's breast cancer label to include Verzenio combo

About a year after Inluriyo (imlunestrant) was initially approved as a monotherapy for certain patients with breast cancer, the FDA has now greenlit the oral selective oestrogen receptor degrader (SERD) for the same disease setting, but in combination with another of Eli Lilly's drugs, the CDK4/6 inhibitor Verzenio (abemaciclib). The US regulator on Friday cleared Lilly's combo for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.Since its solo approval, Inluriyo has reached over half of all patients starting an oral SERD, according to Jacob Van Naarden, president of Lilly Oncology. "Today's full approval extends what Inluriyo in combination with Verzenio can do for patients, with a regimen that has confirmed benefit, is aligned to the clinically proven treatment paradigm of changing therapy at clinical progression, and doesn't introduce burdensome monitoring requirements for patients or physicians," he said in a company release.Dueling SERDsInluriyo's label differs slightly from that of Etcamah (camizestrant), AstraZeneca's recently cleared oral SERD. The UK pharma's entrant in the space was granted accelerated approval by the FDA earlier this month in combination with a CDK4/6 inhibitor for HR-positive, HER2-negative breast cancer patients, but it can only be given if an ESR1 mutation is detected via ctDNA testing during frontline treatment with an aromatase inhibitor (AI) and CDK4/6 inhibitor. The nod for Etcamah came despite a lack of support from the FDA's Oncologic Drugs Advisory Committee, which voted against the biomarker-driven early-switching strategy. Several panel members were not convinced there was enough evidence for a treatment regimen determined by ctDNA testing.AstraZeneca's oral SERD also recently fell short in the frontline setting. In the SERENA-4 trial, Etcamah plus Pfizer's Ibrance (palbociclib) produced a "numerical improvement" on the primary endpoint of progression-free survival versus anastrozole plus Ibrance, but the difference wasn't statistically significant (see – Spotlight On: SERENA-4 miss raises broader concerns over AZ's pipeline).Doubling PFSData supporting the combination of Inluriyo plus Verzenio were generated in the Phase III EMBER-3 trial involving 159 patients with ESR1-mutant metastatic breast cancer. Participants were randomised to receive Inluriyo alone or in combination with Verzenio, after an AI, with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. Within that patient population, adding Verzenio to Inluriyo doubled median progression-free survival (PFS) to 11.1 months compared with a PFS of 5.5 months for Inluriyo alone.Lilly is also evaluating Inluriyo in the adjuvant setting. The Phase III EMBER-4 trial is underway in more than 8000 patients with ER-positive, HER2-negative early-stage breast cancer at increased risk of recurrence following standard of care endocrine therapy, including CDK4/6 inhibitors. Initial data are due next year.

Phase 3Clinical ResultDrug ApprovalAccelerated Approval

100 Deals associated with Anastrozole

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KEGG	Wiki	ATC	Drug Bank
D00960	Anastrozole	L02BG03	DB01217

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fibrous Dysplasia, Polyostotic	United States	Astrazeneca /Cr/	05 Dec 2008
Gynecomastia	United States	Astrazeneca /Cr/	05 Dec 2008
Breast Cancer	Japan	AstraZeneca KK	22 Dec 2000
Metastatic breast cancer	United States	ANI Pharmaceuticals, Inc.	01 Sep 2000
Advanced breast cancer	Australia	AstraZeneca Pty Ltd.	17 Dec 1996
Early Stage Breast Carcinoma	Australia	AstraZeneca Pty Ltd.	17 Dec 1996
Locally advanced breast cancer	United States	ANI Pharmaceuticals, Inc.	27 Dec 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Malignant Neoplasm	Phase 3	Japan	AstraZeneca PLC	07 Nov 2012
Neoplasm Metastasis	Phase 3	Japan	AstraZeneca PLC	07 Nov 2012
Premenopausal breast cancer	Phase 3	Japan	AstraZeneca PLC	01 Oct 2007
Breast cancer recurrent	Phase 3	Japan	Pfizer Inc.	01 Apr 2005
Growth hormone deficiency	Phase 3	United States	AstraZeneca PLC	01 Nov 2001
Estrogen receptor positive breast cancer	Phase 3	United States	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	Japan	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	Belgium	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	Brazil	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	Canada	AstraZeneca PLC	01 Aug 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00541086 (GIM3 FATA, ESMO2026)	Phase 3	Early Stage Breast Carcinoma Adjuvant HR-positive	3,697	Anastrozoletamoxifen (Upfront or after 2 years of tamoxifen)	gctiihzrop(kgxnjbzmzi) = yxetnckzyl kkapljddnf (lcqverqmqc, 76.1 - 81.7)	Negative	23 Oct 2026
				Exemestanetamoxifen (Upfront or after 2 years of tamoxifen)	gctiihzrop(kgxnjbzmzi) = dcfhktvdop kkapljddnf (lcqverqmqc, 70.9 - 77.2)
NCT03490513 (CTgov)	Phase 4	secondary testicular failure \| Obesity	121	anastrozole (1 mg/day) (Anastrozole)	cbksovawck(pimydmburp) = wvmbaclxvi aegfgyzjwj (hbuhbavkjo, 120.0) View more	-	19 Oct 2026
				Placebo (Placebo)	cbksovawck(pimydmburp) = qhffcwlukq aegfgyzjwj (hbuhbavkjo, 85.2) View more
NCT02188745 (POLLY, CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	20	letrozole+Exemestane+17B-estradiol+anastrozole	hyhnsetnnl = zzacmtotfo ntyubvyzyd (obcffkhzyl, bnxpumfayl - kkjxhbjesc) View more	-	25 Sep 2026
NCT06253702 (CTgov)	Phase 4	Cerebrovascular Disorders	22	Orilissa+estradiol (Female Participants Placebo First)	rhyxccitps(fnuzcpgade) = gucmnbvwms gqabeazdmp (gywqtchiuc, 9.35) View more	-	24 Sep 2026
				Orilissa+estradiol (Female Participants Indo First)	rhyxccitps(fnuzcpgade) = sgpyyncyfw gqabeazdmp (gywqtchiuc, 15.88) View more
NCT00053898 (NSABP B-35, Pubmed \| JAMA Surg)	Phase 3	Noninfiltrating Intraductal Carcinoma hormone receptor (HR)-positive	3,104	Tamoxifen	sxdsnmdvmp(gvyhovbpst) = mmxwcpedma lovixwbfmj (amxenhdffy ) View more	Positive	01 Sep 2026
				Anastrozole	sxdsnmdvmp(gvyhovbpst) = nxtzsswltm lovixwbfmj (amxenhdffy ) View more
NCT02206984 (P3-05-14 \| TBCRC037, CTgov)	Phase 2	Invasive Lobular Breast Carcinoma	201	fulvestrant (Fulvestrant)	becttzqksy(elwebviusz) = jilpwdenml adztgtwnsn (jjndwxjccg, 1.1) View more	-	07 Aug 2026
				anastrozole (Anastrozole)	becttzqksy(elwebviusz) = mipkkvikde adztgtwnsn (jjndwxjccg, 1.1) View more
ESMO_GCC2026	Phase 2	Metastatic endometrial cancer estrogen receptor-positive	29	Palbociclib and anastrozole	uyqdtraamj(zorizouekw) = vbuqjyflis njylhlciwv (xwdyudccub ) View more	Positive	18 Jun 2026
NCT02095184 (CTgov)	Not Applicable	Breast Cancer \| Obesity	42	anastrozole (Cohort 1: Normal Weight Anastrozole)	idrdjxrlcg(nyfalclcqd) = ylhgjbyauy zidrrshqvw (lrrqvwaxwi, fhnfcztpty - mwsfauiqfc) View more	-	15 Apr 2026
				anastrozole (Cohort 2: Overweight Anastrozole)	idrdjxrlcg(nyfalclcqd) = mdetlrmzsh zidrrshqvw (lrrqvwaxwi, pbunbtdcpz - dbxslletoi) View more
NCT04272801 (POWER, CTgov)	Phase 2	Early Stage Breast Carcinoma	84	Patient reported outcomes+letrozole+tamoxifen+exemestane+anastrozole	xnxlkpfnfn = wegdzmtdgj vkhvxbfrpq (tukwoozwmk, wnexehbrdq - rwxzalwleo) View more	-	22 Oct 2025
NCT02206984 (TBCRC037, ESMO2025)	-	Hormone receptor negative HER2 positive breast cancer hormone receptor-positive \| HER2-negative	172	Fulvestrant	macuxyaeud(sonbxhxsro): P-Value = 0.042	Positive	17 Oct 2025
				Tamoxifen

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