Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Start Date01 Jan 2026

Sponsor / Collaborator

The University of Chicago

NCT06930859

/ Not yet recruitingNot Applicable

Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia

This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.

Start Date31 Dec 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Letrozole

100 Translational Medicine associated with Letrozole

100 Patents (Medical) associated with Letrozole

5,464

Literatures (Medical) associated with Letrozole

01 Jan 2026·JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

White kidney bean extract improves letrozole-induced polycystic ovary syndrome in rats by regulating the Wnt signaling pathway

Article

Author: Qi, Xinyue ; Zhu, Ya ; Zhong, Lanping ; Zhu, Jiani ; Wu, Xiaorong ; Zhang, Zijuan ; Zhou, Qun ; Deng, Bo ; Gu, Ran

Polycystic ovary syndrome (PCOS) is an endocrine-metabolic disorder characterized by ovarian dysfunction, with limited effective treatments. This study investigates the therapeutic effects and mechanisms of white kidney bean extract (WKBE) in a PCOS rat model. A PCOS model was established using letrozole, followed by intervention with varying doses of WKBE. Serum sex hormone levels, insulin resistance, and metabolic markers were measured. Ovarian histopathology, fibrosis, and apoptosis were assessed. Transcriptomic sequencing was performed on ovarian tissues from control, PCOS, and high-dose WKBE groups. High-dose WKBE significantly ameliorated endocrine-metabolic disturbances in PCOS rats, including reduced testosterone, LH/FSH ratio, insulin resistance, and lipid abnormalities, outperforming low/medium doses. It decreased body weight, ovarian index, and organ fat deposition, repaired ovarian histopathological damage, and reduced fibrosis and apoptosis. Transcriptomic analysis revealed that high-dose WKBE altered the expression of Wnt signaling pathway-related genes, suggesting its therapeutic role may involve modulation of this pathway. High-dose WKBE alleviates endocrine-metabolic dysregulation and ovarian dysfunction in PCOS rats by regulating the Wnt signaling pathway, offering a potential novel therapeutic strategy.

01 Jan 2026·Radiology case reports

Symptomatic bone marrow involvement by metastatic occult HR+/HER2- breast cancer treated with ribociclib and letrozole: A case report

Article

Author: Golemba, Alfredo S ; Tolosa, Raúl E García ; Aguirre Santamaría, Astor A ; Jimenez Bolaño, Adriana L

Visceral crisis (VC) occurs in less than about 15% of patients with de novo metastatic breast cancer (BC). We present a case of a 59-years-old woman who presented with history of bone pain, fatigue, dyspnea on exertion, and weight loss; on physical examination was found no breast nodules, enlarged lymph nodes, or enlarged viscera were palpable. Laboratory tests revealed hemoglobin 5.8 g/dl. PET CT scan showed multiple osteolytic lesions. A bone marrow biopsy was performed, which identified infiltration by an epithelial tumor lesion. Immunohistochemistry showed positivity for CK1/3, CK7, Gata-3, and estrogen and progesterone receptors. HER2 negative (0+). The diagnosis of de novo occult HR+/HER2- metastatic BC was made. Systemic treatment with ribociclib and letrozole was started; the patient experienced clinical improvement of the symptoms, weight gain and improvement in hemoglobin levels. VC in HR+/HER2- metastatic BC is a challenging situation from its definition to its management. In case of availability and quick access, a free CT regimen with CDK4/6i + endocrine therapy could be a option to consider in this patients. This also represents a challenge in terms of cost-effectiveness in the health systems of low-income countries.

31 Dec 2025·ANNALS OF MEDICINE

Genetic variations in CYP2A6 predict efficacy of neoadjuvant letrozole concurrent with chemotherapy in locally advanced hormone receptor-positive breast cancer

Article

Author: Sheng, Xiaonan ; Zhou, Liheng ; Wang, Yaohui ; Yin, Wenjin ; Lin, Yanping ; Lu, Jinsong ; Wu, Yifan

PURPOSE:

We conducted a retrospective exploratory analysis of prospective cohort to investigate the impact of CYP2A6 metabolizer status on predicting the efficacy and prognosis of neoadjuvant chemotherapy combined with letrozole.

METHOD:

Three allelic variants that related to the abolished or reduced activity of CYP2A6 enzyme and 7 other single nucleotide polymorphisms (SNPs) in the CYP2A6 locus were examined from whole blood samples before neoadjuvant treatment, and patients were classified into 3 metabolizer status subgroups ('normal', 'intermediate' and 'slow' metabolizers) according to CYP2A6 genotypes.

RESULT:

Our study included 56 patients received neoadjuvant chemotherapy combined with letrozole. The pCR rate in the CYP2A6 intermediate/slow metabolizers (29.2%) was higher than that in the normal metabolizers (12.5%; p = 0.046). Survival analysis suggested CYP2A6 intermediate/slow metabolizers may have a slightly lower risk of DFS events compared to normal metabolizers. These findings suggested that CYP2A6 metabolizer status might play a crucial role in predicting the efficacy and prognosis of adding letrozole to neoadjuvant chemotherapy.

CONCLUSION:

The CPY2A6 gene polymorphism may be a novel potential predictive and prognostic biomarker for postmenopausal hormone receptor-positive breast cancer patients receiving neoadjuvant chemotherapy combined with letrozole. Our findings have clinical implications for guiding precision endocrine therapy in hormone receptor-positive breast cancer patients.

194

News (Medical) associated with Letrozole

02 Dec 2025

·www.businesswire.com

New Data to be Presented at the 2025 SABCS Demonstrates Potential Expanded Utility of the Breast Cancer Index Test, the Leading Biomarker in Personalizing Endocrine Therapy Duration

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., today announced that 11 studies featuring the Breast Cancer Index® (BCI™) Test will be presented at the 2025 San Antonio Breast Cancer Symposium® (SABCS). Findings from these studies support the company’s ongoing commitment to help inform personalized treatment recommendations for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Building on the test’s established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy,1-7 these new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions. New Data to be Presented at the 2025 SABCS Demonstrates Potential Expanded Utility of the Breast Cancer Index Test, the Leading Biomarker in Personalizing Endocrine Therapy Duration “These data reinforce Hologic’s continued commitment to oncology innovation and advancing precision diagnostics in breast cancer care,” said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. “This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy decision-making and highlights the consistency of the BCI Test’s performance across diverse patient subgroups and sample types.” Among the new findings to be presented, one study, “Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27],” explores the BCI Test’s potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. Results from this translational analysis of the two largest landmark ovarian function suppression (OFS) trials, Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT), support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy.8^* “As we observe an increasing number of women being diagnosed with breast cancer at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life,” said primary study author Dr. Ruth O’Regan, MD. “The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects.” A full list of studies to be presented at the 2025 SABCS conference includes: Poster Session 2: December 10, 2025, 5:00pm – 6:30pm CST Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants. 9 * Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants. 9 * Poster Session 3: December 11, 2025, 12:30pm – 2pm CST Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision. 10 * Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. 8 ^* Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease. 11 * Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns. 12 * Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples. 13 * Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision. 10 * Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. 8 ^* Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease. 11 * Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns. 12 * Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples. 13 * Five additional studies featuring data on the clinical utility of the BCI Test will be presented by external investigators at 2025 SABCS, including: Poster Session 3: December 11, 2025, 12:30pm – 2pm CST Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18] 14 Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10] 15 Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19] 16 Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23] 17 Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18] 14 Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10] 15 Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19] 16 Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23] 17 Poster Session 4: December 11, 2025, 5:00pm – 6:30pm CST Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08] 18 Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08] 18 “The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test,” said Schneiders. “With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy decisions, it’s encouraging to see additional real-world and independent data reinforcing the BCI Test’s impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients.” About the Breast Cancer Index Test The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO® Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.6,7 It is the only test recognized by guidelines to predict which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.6,7 The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com. About Hologic, Inc. Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube. Forward-Looking Statements This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s and its subsidiaries’ products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based. ^Note: Incorporation of refined risk estimates in the results reported by the Breast Cancer Index test are pending appropriate regulatory approvals. For the Breast Cancer Index Intended Uses and Limitations, please visit breastcancerindex.com. *Biotheranostics, Inc. researchers are named authors in this study. Hologic, Breast Cancer Index, BCI and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks are the property of their respective owners. References Zhang Y, et al. Breast Cancer Index identifies early-stage estrogen receptor–positive breast cancer patients at risk for early- and late-distant recurrence. Clin Cancer Res. 2013;19(15):4196-4205. doi:10.1158/1078-0432.CCR-13-0804. Sgroi DC, et al. Prediction of late disease recurrence and extended adjuvant letrozole benefit by the HOXB13/IL17BR biomarker. JNCI J Natl Cancer Inst . 2013;105(14):1036-1042. doi:10.1093/jnci/djt146. Bartlett JMS, et al. Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen–To Offer More? (aTTom) trial. Ann Oncol. 2019;30(11):1776-1783. doi:10.1093/annonc/mdz289. Noordhoek I, et al. Breast Cancer Index predicts extended endocrine benefit to individualize selection of patients with HR‐positive early-stage breast cancer for 10 years of endocrine therapy. Clin Cancer Res. 2021;27(1):311-319. doi:10.1158/1078-0432.CCR-20-2737. Mamounas EP, et al. Breast Cancer Index (BCI) and prediction of benefit from extended aromatase inhibitor therapy in HR+ breast cancer: NRG Oncology/NSABP B-42. J Clin Oncol . 2021;39(15_suppl):501. doi:10.1200/JCO.2021.39.15_suppl.501 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Breast Cancer V.5.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed November 6, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Andre F, et al. J Clin Oncol. 2022;40(16):1816-1837. Referenced with permission from the American Society of Clinical Oncology (ASCO): Clinical Practice Guideline Endorsements for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer. © American Society of Clinical Oncology, 2025. All rights reserved. To view the most recent and complete version of the guideline, go online to https://ascopubs-org.libproxy1.nus.edu.sg/guidelines [ascopubs.org]. ASCO Clinical Practice Guideline makes no warranties of any kind whatsoever regarding their content, use of application and disclaims any responsibility for their application or use in any way. O’Regan R, et al. Identifying premenopausal patients with early-stage hormone receptor–positive node-negative breast cancer at minimal risk of distant recurrence by Breast Cancer Index. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Yadav S, et al. Endocrine sensitivity and predicted benefit of extended endocrine therapy based on Breast Cancer Index (BCI) in BRCA1, BRCA2, and CHEK2 pathogenic variant carriers with ER+/HER2– breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 10, 2025; San Antonio, TX. Chuy V, et al. Breast Cancer Index re-stratifies 21-gene assay risk groups for risk of recurrence and extended endocrine therapy benefit: Final analysis of the BCI Registry Study. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Chumsri S, et al. Prognostic performance of Breast Cancer Index in patients with early-stage HR+ HER2+ breast cancer treated with adjuvant trastuzumab: NCCTG N9831 (Alliance). Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Sandoval-Leon AC, et al. Comparative analysis of Breast Cancer Index testing in Hispanic and non-Hispanic populations. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Kapoor NS, et al. Comparison of Breast Cancer Index scores from core-needle biopsies versus surgical excisions in early-stage breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Tran CC, et al. Guidelines for Breast Cancer Index test before and after Epic software enhancement. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Ogunsesan Y, et al. Higher breast tumor grades could more likely benefit from extended adjuvant endocrine therapy . Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Rupani KV, et al. Correlation between Breast Cancer Index (BCI) and RSClin late in assessing 5–10-year recurrence risk in early-stage hormone receptor–positive breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Essarani M, et al. Retrospective study on Breast Cancer Index testing in a community hospital and analysis of its impact on physician decision-making for extended endocrine therapy in early breast cancer. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. Flood B, et al. Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood . Presented at: San Antonio Breast Cancer Symposium (SABCS); December 11, 2025; San Antonio, TX. SOURCE: Hologic, Inc.

ASCO

24 Nov 2025

·www.globenewswire.com

Arvinas Announces Data Presentations from the Vepdegestrant (ARV-471) Clinical Development Program at the 2025 San Antonio Breast Cancer Symposium (SABCS)

NEW HAVEN, Conn., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that multiple abstracts on vepdegestrant (ARV-471) have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12, 2025 in San Antonio, Texas. Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.* Ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer. The presentation details are as follows: Title: Subgroup analyses of VERITAC-2: A phase 3 trial of vepdegestrant, a PROTAC estrogen receptor (ER) degrader, versus fulvestrant in ER-positive/ human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC)Presenting Author: Erika P. HamiltonPresentation Number: PD10-03Presentation Type: Poster Spotlight PresentationSession: Poster Spotlight 10: Novel Combinations with Endocrine TherapyDate: Friday, December 12, 2025Session Time: 7:00–8:30 AM CTPresentation Time: 7:36–7:39 AM CT Title: Circulating tumor DNA (ctDNA) biomarker analyses of a phase 1/2 study evaluating vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC)Presenting Author: Seth A. WanderPresentation Number: PS2-07-24Presentation Type: Poster PresentationSession: Poster Session 2Date: Wednesday, December 10, 2025Session Time: 5:00–6:30 PM CT Title: Real-world prevalence of ESR1 mutations (ESR1m) among patients with estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) after first-line (1L) treatment with endocrine therapy (ET) and/or a cyclin dependent kinase 4/6 inhibitor (CDK4/6i)Presenting Author: David ChandiwanaPresentation Number: PS1-11-09Presentation Type: Poster PresentationSession: Poster Session 1Date: Wednesday, December 10, 2025Session Time: 12:30–2:00 PM CT Title: I-SPY2 Endocrine Optimization Pilot (EOP): Neoadjuvant vepdegestrant monotherapy or in combination with letrozole or abemaciclib in molecularly selected patients with stage 2/3 HR+ HER2-negative breast cancer (BC)Presenting Author: Jo ChienPresentation Number: PD10-02Presentation Type: Poster Spotlight PresentationSession: Poster Spotlight 10: Novel Combinations with Endocrine TherapyDate: Friday, December 12, 2025Session Time: 7:00–8:30 AM CTPresentation Time: 7:33–7:36 AM CT The I-SPY2 EOP trial is sponsored by Quantum Leap. Title: A phase 1/2 trial evaluating the safety, tolerability, and efficacy of the KAT6 inhibitor, PF-07248144, in combination with vepdegestrant in patients with ER+/HER2− locally advanced or metastatic breast cancerPresenting Author: Fengting YanPresentation Number: PS5-09-30Presentation Type: Poster Presentation (Trial in Progress Poster)Session: Poster Session 5Date: Friday, December 12, 2025Session Time: 12:30–2:00 PM CT The full abstracts can be accessed via the SABCS online program. About VepdegestrantVepdegestrant is an investigational, orally bioavailable PROTAC estrogen receptor degrader. In the VERITAC-2 Phase 3 study, vepdegestrant demonstrated statistically significant and clinically meaningful improvement in progression free survival compared to fulvestrant in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The U.S. Food and Drug Administration (FDA) is reviewing the filed New Drug Application (NDA) for vepdegestrant. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer share worldwide development costs, commercialization expenses, and profits. *In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the commercialization and potential further development of vepdegestrant. About ArvinasArvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, Arvinas is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including ARV-102, targeting LRRK2 for neurodegenerative disorders; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic and colorectal cancers; and vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: vepdegestrant’s potential as a monotherapy for estrogen receptor positive (“ER+”)/human epidermal growth factor receptor 2 negative (“HER2-”) advanced or metastatic breast cancer with estrogen receptor 1 mutations in the second line-plus setting; vepdegestrant potential as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer; and Arvinas, Inc.’s (“Arvinas”) and Pfizer, Inc.’s (“Pfizer”) plan to jointly select a third party for the commercialization and potential further development of vepdegestrant. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “goal,” “potential,” “will,” “would,” “could,” “should,” “look forward,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: risks related to Arvinas’ expectations regarding the potential clinical benefit of vepdegestrant to patients; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant as a monotherapy; whether the VERITAC-2 clinical trial will meet the secondary endpoint for overall survival; whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant; risks and uncertainties related to the potential selection of a third party for the commercialization and potential further development of vepdegestrant; uncertainties relating to regulatory applications and related approval timelines, including with respect to the New Drug Application for vepdegestrant; risks related to seeking U.S. Food and Drug Administration (“FDA”) approval of vepdegestrant and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of vepdegestrant; Arvinas’ ability to protect its intellectual property portfolio; Arvinas’ reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas’ cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release. Contacts Investors:Jeff Boyle+1 (347) 247-5089Jeff.Boyle@arvinas.com Media:Kirsten Owens+1 (203) 584-0307Kirsten.owens@arvinas.com

Phase 3Fast TrackClinical Result

18 Nov 2025

·www.businesswire.com

Genentech’s Giredestrant Becomes the First Oral SERD to Show Superior Invasive Disease-Free Survival in Early Breast Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive Phase III results from the lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast cancer. The study met its primary endpoint at a pre-planned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant versus standard-of-care endocrine therapy. lidERA is the first Phase III trial of a selective estrogen receptor degrader (SERD) to demonstrate a significant benefit in the adjuvant setting. The majority of breast cancer cases are diagnosed at an early stage. “Today’s results underscore the potential of giredestrant as a new endocrine therapy of choice for people with early-stage breast cancer, where there is a chance for cure,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Given that ER-positive breast cancer accounts for approximately 70% of cases diagnosed, these findings – together with recent data in the advanced ER-positive setting – suggest that giredestrant has the potential to improve outcomes for many people with this disease.” Overall survival data were immature at the time of interim analysis, but a clear positive trend was observed. Giredestrant was well tolerated and adverse events were consistent with its known safety profile, with no unexpected safety findings observed. Data from lidERA will be presented at an upcoming medical meeting and shared with health authorities with the aim of bringing this potential treatment option to patients around the world. ER-positive breast cancer accounts for approximately 70% of breast cancer cases. Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence. lidERA is the second positive Phase III readout for giredestrant following evERA Breast Cancer, which was presented at the European Society for Medical Oncology Congress 2025. The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels). This growing body of evidence supports the potential of giredestrant to meaningfully improve outcomes compared with standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer. Genentech’s extensive giredestrant clinical development program spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible. About the lidERA Breast Cancer study lidERA Breast Cancer [NCT04961996] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Over 4,100 patients were enrolled in the study. The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers). Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety. About estrogen receptor (ER)-positive breast cancer Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type. ER-positive breast cancer accounts for approximately 70% of breast cancer cases. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth. Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives. About giredestrant Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist. Giredestrant is designed to block estrogen from binding to the estrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells. Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible: Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996 ) Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340 ) Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009 ) Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK) 4/6 inhibitor versus fulvestrant plus a CDK 4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748 ) Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798 ) About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in multiple types of breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Genentech Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Phase 3Clinical Result

100 Deals associated with Letrozole

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KEGG	Wiki	ATC	Drug Bank
D00964	Letrozole	L02BG04	DB01006

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Indication	Country/Location	Organization	Date
Infertility	Japan	Novartis Pharma AG	25 Feb 2022
Metastatic breast cancer	United States	Novartis Pharmaceuticals Corp.	25 Jul 1997
Breast Cancer	Sweden	Novartis AG	10 Dec 1996

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Indication	Highest Phase	Country/Location	Organization	Date
Endometrioid carcinoma ovary	Phase 3	Austria	Hoffmann-La Roche, Inc.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Austria	Novartis Pharmaceuticals Corp.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Germany	Novartis Pharmaceuticals Corp.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Germany	Hoffmann-La Roche, Inc.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Switzerland	Hoffmann-La Roche, Inc.	05 Nov 2020
Endometrioid carcinoma ovary	Phase 3	Switzerland	Novartis Pharmaceuticals Corp.	05 Nov 2020
Fallopian Tube Carcinoma	Phase 3	Austria	Hoffmann-La Roche, Inc.	05 Nov 2020
Fallopian Tube Carcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	05 Nov 2020
Fallopian Tube Carcinoma	Phase 3	Germany	Hoffmann-La Roche, Inc.	05 Nov 2020
Fallopian Tube Carcinoma	Phase 3	Germany	Novartis Pharmaceuticals Corp.	05 Nov 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04735367 (Pubmed \| Breast Cancer)	Phase 2	ER-positive/HER2-negative Breast Cancer First line ER+/HER2−	42	Palbociclib plus letrozole	zqdvrrweam(nbkioqocxc) = nagbtxyhfh zwamzcuqmm (fdhmylikcj, 64.3 - NE) View more	Positive	01 Nov 2025
NCT04272801 (POWER, CTgov)	Phase 2	Early Stage Breast Carcinoma	84	Patient reported outcomes+letrozole+tamoxifen+exemestane+anastrozole	byoxrzvwff = jxbtlpetov puubunfjbs (nihmjgbian, xoxhrrtiyl - dmfcyfdgzo) View more	-	22 Oct 2025
NCT04486911 (MUKDEN 01, ESMO2025)	Phase 2	ER positive, PR positive, HER2 positive breast cancer First line \| Neoadjuvant ER Positive \| PR Positive \| HER2 Positive	81	Pyrotinib+Letrozole+Dalpiciclib	ewcljqjeck(nqvxloevgu) = qvmiszwgeg xxlyvjmzsd (vsrmhjtrdg, 88.6 - 99.1) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2-	1,267	Letrozole plus Palbociclib	jgreufvkcy(rvaqugxxls): HR = 0.59 (95.0% CI, 0.51 - 0.69) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable		1,267	Letrozole plus Placebo		Positive	17 Oct 2025
NCT00001521 (CTgov)	Phase 3	Adrenal Hyperplasia, Congenital \| Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency	66	Fludrocortisone+Letrozole+Testolactone+Flutamide+Hydrocortisone (Investigational Therapy)	kgslkbvbbz(bsstoqivzx) = viikqkzdtu fbableqwal (rfxpxpcpto, 0.93) View more	-	12 Jun 2025
NCT00001521 (CTgov)	Phase 3		66	Fludrocortisone+Hydrocortisone (Standard Therapy)	kgslkbvbbz(bsstoqivzx) = oojfmylgbd fbableqwal (rfxpxpcpto, 0.89) View more	-	12 Jun 2025
ChiCTR2400081280 (ASCO2025) Manual	Phase 4	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HR Positive \| HER2 Negative	23	Dalpiciclib + Chidamide + Letrozole	pyhcrursbi(wfheynfume) = abqyfavvfo eeubldfiin (kdcocrnyto, 5.5 - 49.5) View more	Positive	30 May 2025
NCT03675893 (Phase 2 study of letrozole, abemaciclib, and metformin in estrogen receptor (ER)-positive recurrent endometrial cancer (EC), ASCO2025)	Phase 2	Recurrent Endometrial Cancer ER positive \| MMRD	25	Letrozole/Abemaciclib/Metformin	mqgokonmqg(cgrzcssqei) = ixkxzdkfve wvzslyspmn (keopnprtwd, 14.9% - 53.5) View more	Positive	30 May 2025
NEOLETEXE (ESMO_BC2025)	Not Applicable	HR Positive/HER2 Negative/Node positive breast cancer Neoadjuvant Ki67	102	Letrozole	ecqsthtelr(eviycmssac) = puhprcmyjm whmztqfuld (nbpxzxcevi ) View more	Positive	14 May 2025
NEOLETEXE (ESMO_BC2025)	Not Applicable		102	Exemestane	ecqsthtelr(eviycmssac) = mjdqnlhgml whmztqfuld (nbpxzxcevi ) View more	Positive	14 May 2025
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HER3	122	HER3-DXd	lwbmpjzgcg(fyeufwbzcj) = vbimashhjn knecetaphr (cafeearnlk )	Positive	14 May 2025
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	Phase 2		122	HER3-DXd + letrozole	lwbmpjzgcg(fyeufwbzcj) = rlddbzvbeo knecetaphr (cafeearnlk )	Positive	14 May 2025
Phase 2 study of letrozole, abemaciclib and metformin (AACR2025)	Phase 2	Recurrent Endometrial Cancer ER positive \| RB1 \| CCNE1 ... View more	25	Letrozole/Abemaciclib/Metformin	myuggjtdej(qcxefqhcdo) = swdyvkzagt gavgoazqtl (ekscxvvgcb, 14.9% - 53.5) View more	Positive	29 Apr 2025

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