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 Jul 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06905301

/ Not yet recruitingNot Applicable

Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.

Start Date31 Jul 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

6,201

Literatures (Medical) associated with Letrozole

31 Dec 2025·GYNECOLOGICAL ENDOCRINOLOGY

Study on the mechanism of action of berberine combined with Jianpi Yishen Huazhuo formulation in treating obese polycystic ovary syndrome by activating PI3K/AKT signaling pathway

Article

Author: Feng, Yahong ; Du, Cuizhong ; Liang, Lijun ; Ye, Gaxi ; Ahmad, Aqsa ; Ji, Dejiang ; Zhang, Xiaojing ; Zhang, Yan

OBJECTIVES:

This study aims to investigate the effects and potential mechanisms of berberine in conjunction with Jianpi Yishen Huazhuo formulation (JPYSHZF) on obese rats that serve as a model for polycystic ovary syndrome (PCOS).

METHODS:

Letrozole combined with high-fat diet (HFD) was used to establish an overweight PCOS rat model. After successful modeling, each intervention group was monitored for 28 d. An oral glucose tolerance test (OGTT) is performed to assess glucose metabolism. Enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of sex hormones and serum levels of gastrointestinal hormones in rats. Biochemical analyzers were used to assess blood lipid levels. The protein expression levels of p38, PI3K, GLUT4, and AKT in ovarian tissue were demonstrated using Western Blotting (WB). Real-time fluorescence quantitative PCR (RT-qPCR) was used to measure the mRNA expression levels of p38, PI3K, GLUT4 and AKT in the same tissue. The morphological changes of ovarian tissue were observed using Hematoxylin-eosin (HE).

RESULTS:

Treatment with berberine in conjunction with JPYSHZF has been shown to reduce serum testosterone T and luteinizing hormone (LH) levels while increasing serum follicle-stimulating hormone (FSH) and E2 levels. This combination therapy also decreases the LH/FSH ratio and ameliorates polycystic ovary-like pathological changes in the ovaries of rats with PCOS. Additionally, this treatment decreases serum TC, TG, and LDL-c levels while increasing HDL-c levels. It also reduces levels of GLU and Ghrelin while enhancing levels of CCK, PYY, and GLP-1. Furthermore, the relative 6 of PI3K and AKT proteins, as well as the mRNA levels of PI3K, GLUT4, and AKT, were found to be increased.

CONCLUSIONS:

Berberine combined with JPYSHZF can improve the sex hormone levels, ovarian function, glucose and lipid metabolism levels, and gastrointestinal hormone levels in obese PCOS rats by activating the PI3K/AKT signaling pathway, thereby playing a role in treating obese PCOS.

31 Dec 2025·GYNECOLOGICAL ENDOCRINOLOGY

Animal experiments and network pharmacology to explore the anti-inflammatory mechanism of dapagliflozin in the treatment of polycystic ovary syndrome

Article

Author: Zhang, Zhen ; Bai, He ; Liu, Yong ; Li, Luxin ; Guan, Huilin ; Song, Xueqing ; Yong, Zihao ; Guo, Xiaomeng ; Wang, Chunhua

BACKGROUND:

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder associated with chronic low-grade inflammation of the ovary. Sodium glucose co-transporter 2 (SGLT2) inhibitors are a class of antidiabetic drugs that can reduce the weight and hyperglycemia of type 2 diabetes patients. Dapagliflozin is a highly selective, orally active and reversible inhibitor of the human SGLT2. However, the role of dapagliflozin in regulating PCOS remains unclear.

METHODS:

In this study, 24 six-week-old female Sprague Dawley (SD) rats were randomly divided into control, letrozole, and letrozole + dapagliflozin groups. PCOS model rats were produced by gavage administration of letrozole for 21 days. The intervention was conducted after the gavage administration of dapagliflozin for 14 days to evaluate the estrous cycle and ovarian imaging changes of the rats in each group. We observed changes in the weight, ovarian weight, and ovarian morphology of the rats in each group. Pathological changes in the ovaries were examined by H&E staining, changes in ovarian tissue cell apoptosis were identified using TdT-mediated dUTP Nick-End Labeling (TUNEL) staining, and changes in inflammation-related factors were detected using immunohistochemistry and Western blotting analysis. Network pharmacology was used to predict the inflammatory targets and pathways affected by dapagliflozin in treating PCOS, and the potential interactions between dapagliflozin and inflammation-related target proteins were evaluated through molecular docking.

RESULTS:

Our results demonstrated that dapagliflozin treatment significantly improved PCOS symptoms, recovered ovarian morphology and physiological functions, and reduced the apoptosis of ovarian cells after drug intervention. Dapagliflozin treatment also reduced the levels of pro-inflammatory cytokines such as IL-1β, IL-6, and TNF-α, indicating its anti-inflammatory properties. Furthermore, network pharmacology identified 26 intersecting target genes relevant to inflammation in PCOS, with subsequent molecular docking simulations revealing strong binding affinities of dapagliflozin to key targets, including AKT1 and TP53.

CONCLUSIONS:

These findings suggest that dapagliflozin exerts beneficial effects on PCOS by ameliorating ovarian dysfunction and reducing inflammation. Dapagliflozin represents a promising therapeutic candidate for managing PCOS, warranting further clinical investigation to explore its full potential in treating this multifaceted disorder.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Exploring the role of Myo-inositol in alleviating insulin resistance in polycystic ovary syndrome through the AMPK/GLUT4 pathway

Article

Author: He, Jiajin ; Song, Lihua ; Liu, Nannan ; Song, Guihong ; Tang, Saisai ; Yu, Yiping

BACKGROUND:

Polycystic ovary syndrome (PCOS) is a multifactorial disorder associated with insulin resistance, hyperandrogenism, and metabolic dysfunction. Myo-inositol, a promising therapeutic alternative, may improve glucose and lipid metabolism through the 5'-adenosine monophosphate-activated protein kinase (AMPK)-glucose transporter type 4 (GLUT4) pathway. This study aimed to investigate the molecular and metabolic effects of Myo-inositol in a letrozole-induced rat model of PCOS.

METHODS AND RESULTS:

We divided rats into six groups: controls, PCOS, and different doses of Myo-inositol- or metformin-treated groups. We examined the rat blood glucose, insulin, lipid profiles, and hormone levels alongside ovarian histology and AMPK/GLUT4 expression via polymerase chain reaction and western blotting assays. Myo-inositol treatment demonstrated dose-dependent improvements in glucose homeostasis, lipid profiles, and GLUT4 expression, with high-dose treatment reducing glucose by 0.85-fold and improving lipid metabolism compared to metformin treatment. Ovarian histology revealed partial restoration of follicular development, and AMPK activation supported enhanced glucose uptake.

CONCLUSIONS:

Myo-inositol effectively alleviated insulin resistance and metabolic dysfunction, offering a promising alternative to conventional PCOS treatments.

175

News (Medical) associated with Letrozole

26 May 2025

·www.globenewswire.com

CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubled progression-free survival in the first-line setting1 The Itovebi-based regimen also demonstrated a statistically significant and clinically meaningful benefit in overall survival (OS) in the final OS analysis Final OS data will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting 23 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. If approved, the Itovebi-based regimen has the potential to transform the standard of care in this first-line setting, where treatments are currently limited.1 A final decision regarding the approval is expected from the European Commission in the near future. “The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is further enforced by the recent final overall survival results from the INAVO120 study, showing the regimen can meaningfully extend survival.” The presence of a PIK3CA mutation, found in approximately 40% of hormone receptor (HR)-positive breast cancers, can make the disease more aggressive and worsen survival outcomes.2,3 This underscores the importance of testing for PIK3CA mutations prior to first-line treatment so that people with a poor prognosis can benefit from an effective, PI3K-targeted therapy as soon as possible. The CHMP’s positive opinion is based on the phase III INAVO120 results, published in the New England Journal of Medicine in October 2024, which showed a 57% reduction in the risk of disease worsening or death (progression-free survival [PFS]) with the Itovebi-based regimen compared with palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p1 The PFS benefit was consistent across all pre-specified subgroups, including people whose disease had spread to three or more locations, characterised as difficult-to-treat disease.1 The Itovebi-based regimen was well tolerated, with no new safety signals observed.1 Positive topline results from the final overall survival (OS) analysis, announced in January 2025, showed a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen. OS data were immature at the time of primary analysis, but a clear positive trend was observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338 (boundary of 0.0098)).1 The full results from the OS analysis will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting. The Itovebi-based regimen is approved for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer in the United States, Switzerland, Canada, Australia, United Arab Emirates and China, with data from INAVO120 under review with other global health authorities. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations.4-7 We are exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. Itovebi is an oral, targeted treatment that has been shown to provide well-tolerated and durable disease control in people with advanced PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.1-3 Itovebi has been designed to help minimise the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.8,9 The INAVO120 study [NCT04191499] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.4 The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.4 The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause.4 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.4 Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored phase III clinical studies in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations:5-7 in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862). in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trastuzumab for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239). in combination with a CDK4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in the first-line setting in PIK3CA-mutated HR-positive/HER2-negative, endocrine-sensitive breast cancer (INAVO123; NCT06790693). HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.10,11 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to one or both hormones – oestrogen or progesterone – which can contribute to tumour growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.11-13 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.3 Roche 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 human epidermal growth factor 2-positive and triple-negative 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 oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.10,11 Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. References [1] Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96. [2] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22:1002. [3] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179. [4] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499. [5] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05646862. [6] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239. [7] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 April]. Available from: https://clinicaltrials.gov/study/NCT06790693. [8] Juric D, et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05. [9] Hong R, et al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates robust efficacy in PIK3CA mutant breast cancer models as a single agent and in combination with standard of care therapies. Cancer Res. 2018;78(4):4-14. [10] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 April]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. [11] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696. [12] Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20. [13] Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1):10. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCODrug Approval

24 Apr 2025

·www.prnewswire.com

IBRANCE's Market Growth Marks a Significant Step Forward in Metastatic HR+/HER2− Breast Cancer Treatment Landscape | DelveInsight

Since its launch in 2015, it has been prescribed to more than 200,000 patients globally. The drug is currently approved for use in both men and women, expanding its market potential. Despite facing competition from other CDK4/6 inhibitors like Novartis' KISQALI and Eli Lilly's VERZENIO, IBRANCE maintains a strong position in the metastatic setting. LAS VEGAS, April 24, 2025 /PRNewswire/ -- DelveInsight's " IBRANCE Market Size, Forecast, and Market Insight Report" highlights the details around IBRANCE, a CDK4/6 inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of IBRANCE. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer's IBRANCE (palbociclib) Overview IBRANCE is an oral medication that inhibits CDKs 4 and 6, which are crucial regulators of the cell cycle that drive cellular progression. In the U.S., IBRANCE is approved for treating adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. It is used in combination with an aromatase inhibitor as a first-line endocrine therapy for postmenopausal women or men or with fulvestrant for patients whose disease has progressed after endocrine treatment. IBRANCE is currently authorized in over 90 countries and has been prescribed to more than 200,000 patients worldwide. Learn more about IBRANCE projected market size for metastatic HR+/HER2− breast cancer @ IBRANCE Market Potential The HR+ HER2- subtype is the most commonly found type of breast cancer, characterized by cancer cells that have estrogen and progesterone receptors but do not overexpress HER2. A patient's journey typically begins with the onset of concerning symptoms, leading to a comprehensive clinical evaluation and various imaging tests. DelveInsight estimates that approximately 211K new cases of HR+/HER2– breast cancer occurred in the US in 2024. CDK4/6 inhibitors currently dominate the first-line treatment market and represent a significant advancement in the management of HR+/HER2-ve breast cancer. The data from large, randomized clinical trials are both strong and consistent. While single-agent endocrine therapies have shown limited benefits in the first and subsequent treatment lines for women with ER-positive metastatic breast cancer (mBC), combination therapies have emerged as a more effective option for many patients. In recent years, the treatment landscape for HR+/HER2−ve breast cancer has been transformed with the introduction of highly active targeted therapies, including CDK4/6 inhibitors, mTOR inhibitors, PARP inhibitors, new oral SERDs, and PI3K inhibitors. These advances have expanded the range of treatment options and improved survival outcomes for these patients. The market for metastatic HR+/HER2− breast cancer in the 7MM is projected to grow during the forecast period (2025–2034) due to the introduction of several novel therapies in the market. Discover more about the metastatic HR+/HER2− breast cancer market in detail @ Metastatic HR+/HER2− Breast Cancer Market Report Emerging Competitors of IBRANCE Some of the drugs in the pipeline include Gedatolisib (Celcuity), ARV-471 (Arvinas and Pfizer), OP-1250 (Olema Pharmaceuticals), KEYTRUDA (Merck), and Rupitasertib (Evexta Bio), among others. In December 2024, Arvinas and Pfizer presented preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic ER+/HER2- breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2024. In December 2024, Olema Pharmaceuticals presented clinical results from the ongoing Phase Ib/II study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer at SABCS 2024. To know more about the number of competing drugs in development, visit @ IBRANCE Market Positioning Compared to Other Drugs Key Milestones of IBRANCE In February 2021, Pfizer Inc. announced that the U.S. Patent and Trademark Office (USPTO) has granted a U.S. Patent Term Extension (PTE) certificate for IBRANCE. This extension prolongs the validity of U.S. Patent No. RE47,739 ('739) by over four years, now lasting until March 5, 2027. In April 2019, Pfizer announced that the FDA has approved a supplemental New Drug Application (sNDA) to broaden the uses of IBRANCE in combination with an aromatase inhibitor or fulvestrant, now including men with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced or metastatic breast cancer. In March 2017, Pfizer Inc. revealed that the FDA has approved a supplemental New Drug Application (sNDA) for IBRANCE, its pioneering cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, following the positive outcomes from the confirmatory Phase 3 trial PALOMA-2. In September 2016, Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive recommendation for the marketing authorization of IBRANCE® (palbociclib) in the European Union (EU). This recommendation is for its use in treating women with hormone receptor-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. In February 2016, Pfizer announced that the FDA has approved a new indication for IBRANCE 125mg capsules, expanding its use. The approval allows IBRANCE to be used in combination with fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in women whose disease has progressed after endocrine therapy. In February 2015, Pfizer announced that the FDA granted accelerated approval for IBRANCE in combination with letrozole to treat postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as the initial endocrine-based therapy for their metastatic disease. Discover how IBRANCE is shaping the metastatic HR+/HER2− breast cancer treatment landscape @ IBRANCE Drug IBRANCE Market Dynamics IBRANCE is a targeted therapy that has revolutionized the treatment of hormone receptor-positive, HER2-negative breast cancer, particularly in combination with aromatase inhibitors or letrozole. Developed by Pfizer, IBRANCE was one of the first CDK4/6 inhibitors approved by the FDA for metastatic breast cancer, and its approval has significantly changed the treatment landscape. The drug works by inhibiting cyclin-dependent kinases 4 and 6, which are key regulators of the cell cycle, thus preventing cancer cells from proliferating. Its market dynamics have been shaped by the growing demand for targeted therapies, as well as the increasing focus on precision medicine and improved patient outcomes. The global market for IBRANCE has been positively impacted by its proven efficacy in clinical trials and its ability to extend progression-free survival in breast cancer patients. The drug's market dominance is underpinned by its widespread acceptance and adoption by oncologists worldwide. However, competition is intensifying, with other CDK4/6 inhibitors such as VERZENIO (abemaciclib) and KISQALI (ribociclib) entering the market, offering similar benefits but with some distinct clinical profiles. This competitive landscape has led to strategic pricing and marketing strategies by Pfizer, aiming to maintain IBRANCE's market leadership while managing pressures from generic alternatives. Additionally, the evolving reimbursement landscape and regulatory policies around oncology drugs are crucial factors influencing the market dynamics. Health insurers and government healthcare programs often scrutinize the cost-effectiveness of cancer treatments, which can impact the pricing and accessibility of IBRANCE in different markets. Another factor is the rising focus on combination therapies, as IBRANCE is often used in conjunction with other drugs like letrozole, which boosts its efficacy and market potential. The shift toward personalized cancer treatment regimens is expected to continue fueling demand for CDK4/6 inhibitors like IBRANCE, especially in more advanced stages of breast cancer. In terms of geographical markets, IBRANCE has seen significant uptake in North America and Europe, where the healthcare infrastructure supports innovative cancer therapies. However, emerging markets, where the economic barriers to accessing expensive cancer treatments can be higher, present a challenge to the widespread use of IBRANCE. Pfizer's ongoing efforts to expand in these regions, through partnerships and pricing adjustments, will be key to ensuring continued growth in global market share. Overall, the IBRANCE market is poised for steady growth, driven by clinical advancements, increasing breast cancer diagnoses, and the continual push toward more targeted, effective therapies. Dive deeper to get more insight into IBRANCE's strengths & weaknesses relative to competitors @ IBRANCE Market Drug Report Table of Contents Related Reports Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies, including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key breast cancer companies including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. Metastatic Breast Cancer Pipeline Metastatic Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic breast cancer companies, including Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd, Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc, Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., Taizhou Hanzhong biomedical co. LTD, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Phase 1Clinical Result

27 Feb 2025

·www.echemi.com

AstraZeneca's Next-Gen Oral SERD Shows Promising Results in Breast Cancer Trial

On February 26, 2025, AstraZeneca announced positive mid-term results from the Phase III SERENA-6 trial for its oral selective estrogen receptor degrader (SERD) camizestrant. The study demonstrated statistically and clinically significant improvements in progression-free survival (PFS) when combined with CDK4/6 inhibitors such as palbociclib, ribociclib, or abemaciclib. This marks camizestrant as the first and only oral SERD proven to provide first-line treatment benefits when used with approved CDK4/6 inhibitors. The SERENA-6 trial assessed the efficacy and safety of switching to camizestrant in patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer harboring ESR1 mutations. The study compared the camizestrant combination therapy to the standard care of continuing with aromatase inhibitors like anastrozole or letrozole alongside CDK4/6 inhibitors. While key secondary endpoints such as PFS2 and overall survival (OS) remain immature at this stage, there is a noted trend towards improved PFS2 in the camizestrant group. The trial will continue as planned to further evaluate these critical secondary endpoints. Notably, SERENA-6 is the first global, double-blind Phase III trial utilizing circulating tumor DNA (ctDNA) to guide the detection of endocrine resistance. This innovative approach allows for early identification of endocrine resistance signs and the emergence of ESR1 mutations during routine tumor scans. Upon detection of ESR1 mutations without disease progression, patients transitioned from aromatase inhibitor therapy to camizestrant while maintaining treatment with the same CDK4/6 inhibitor. François-Clément Bidard, a professor of medical oncology at Université Versailles-Saint-Quentin, who is also the principal investigator of the trial, stated, “Patients urgently need new therapies to delay disease progression during first-line endocrine therapy. The SERENA-6 trial shows that transitioning to camizestrant after the emergence of ESR1 mutations can delay disease progression and extend the benefits of first-line treatment, representing a significant step forward for patients and a potential shift in clinical practice.” Susan Galbraith, Executive Vice President of Oncology Research and Development at AstraZeneca, noted that these impressive results indicate camizestrant’s versatility in combination with approved CDK4/6 inhibitors, offering a promising new treatment option for one-third of HR+ HER2-negative advanced breast cancer patients who develop ESR1 mutations while receiving aromatase inhibitors with CDK4/6 inhibitors. This pivotal outcome brings AstraZeneca closer to establishing camizestrant as a new standard of care, aiming to transform treatment paradigms in HR+ breast cancer. Globally, approximately 200,000 HR+ breast cancer patients receive first-line drug treatment, typically involving endocrine therapy targeting estrogen receptor-driven disease, often in conjunction with CDK4/6 inhibitors. However, many advanced patients develop resistance to these treatments. ESR1 mutations are key drivers of this resistance and are widely tested in clinical practice, becoming more prevalent as the disease progresses and associated with poor outcomes. About 30% of endocrine-sensitive HR+ patients experience ESR1 mutations during first-line treatment without disease progression.

Phase 3Clinical Result

100 Deals associated with Letrozole

External Link

KEGG	Wiki	ATC	Drug Bank
D00964	Letrozole	L02BG04	DB01006

R&D Status

Approved

10 top approved records.

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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

Developing

10 top R&D records.

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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

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEOLETEXE (ESMO_BC2025)	Not Applicable	HR Positive/HER2 Negative/Node positive breast cancer Neoadjuvant Ki67	102	Letrozole	pmizdfzjgg(lhokcomwtt) = ruzxlcyqzu fqlcgqsgqa (dinbvpwtmx ) View more	Positive	14 May 2025
				Exemestane	pmizdfzjgg(lhokcomwtt) = uazqqggiev fqlcgqsgqa (dinbvpwtmx ) View more
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HER3	122	HER3-DXd	csitxcylop(mlqnjodldx) = nwgbebepfj ebfgjmgxzo (upyqkshign )	Positive	14 May 2025
				HER3-DXd + letrozole	csitxcylop(mlqnjodldx) = ghavedeslh ebfgjmgxzo (upyqkshign )
Phase 2 study of letrozole, abemaciclib and metformin (AACR2025)	Phase 2	Recurrent Endometrial Cancer ER positive \| RB1 \| CCNE1 ... View more	25	Letrozole/Abemaciclib/Metformin	hpxjnfsikd(eqxejrftdy) = cpjzcyhrab vaivebvpbj (syfgehympe, 14.9% - 53.5) View more	Positive	29 Apr 2025
NCT05206448 (CLC II, CTgov)	Phase 4	Polycystic Ovary Syndrome \| Infertility \| Anovulation	190	letrozole (Letrozole)	twmqlkomko = wjaionlgan rqbnceqzue (zexvpuutkn, yimyqffagz - muvxsskewf) View more	-	15 Apr 2025
				letrozole+Clomiphene citrate (Letrozole + Clomiphene Citrate)	twmqlkomko = xjvifjmdmu rqbnceqzue (zexvpuutkn, xifhgrwtuv - ohbwgpzvpy) View more
NCT03774472 (CTgov)	Phase 1/2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	15	HCQ (HCQ at 400 mg)	lmrkanhzcx = euxxndlnjr jveiwskuer (jebrsrfytl, smbwmmtlft - dfifvpskct) View more	-	17 Feb 2025
				HCQ (HCQ at 600 mg)	lmrkanhzcx = yxykucqmvd jveiwskuer (jebrsrfytl, nvgacuxjgb - yqgobwxjcx) View more
NCT05512780 (DARLING 01, Pubmed \| Breast Cancer Res) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HER2 Negative \| Hormone Receptor Positive	29	Dalpiciclib + Letrozole	xlihdsutjz(emvsuscryt) = ulbqszgvna llgmclfuue (xpvislvbvw ) View more	Positive	13 Feb 2025
NCT04294225 (CTgov)	Phase 2	Invasive Mammary Carcinoma \| Early Stage Breast Carcinoma	161	Letrozole+anastrozole	nprbqwpubt = rubgqcvsil ceecmfzylt (iqltwfigyb, zbylzydagb - ihwbgggqsa) View more	-	28 Jan 2025
NCT00382070 (NRG Oncology/NSABP B-42, Pubmed \| J Clin Oncol)	Phase 3	Hormone receptor positive breast cancer MammaPrint (MP)	-	Letrozole (MammaPrint high risk (MP-HR))	thhwtwqrnq(fnbynffomu) = ttfmsdeocx vqosmgrvel (ndkycvmpwf, 0.34 - 1.24)	Positive	20 Oct 2024
				Letrozole (MammaPrint low risk (MP-LR))	thhwtwqrnq(fnbynffomu) = oybbdiilft vqosmgrvel (ndkycvmpwf, 0.25 - 0.74) View more
NCT01127295 (PHACS, Pubmed)	Phase 4	Hormone receptor positive breast cancer Adjuvant CYP2A6 genotype	617	letrozole (CYP2A6 genotype)	gjwnecnnxw(kbdrevfihc) = Early relapse (19 patients) was not associated with model-estimated, concentration-based or declared adherence in the total population (p = 0.41, p = 0.37 and p = 0.45, respectively) tymloypxhi (tgjppnyaeg )	Positive	01 Aug 2024
NCT05918718 (Pubmed)	Phase 1/2	Pregnancy, Ectopic serum beta-human chorionic gonadotropin	88	Methotrexate	lnpktloaje(wydsaeeuyx) = hloihdkias qoinglbqbe (vninxzpwhz )	Positive	17 Jun 2024
				5-day Letrozole	lnpktloaje(wydsaeeuyx) = pvvxfpglhk qoinglbqbe (vninxzpwhz ) View more

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