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 Date07 Jul 2026

Sponsor / Collaborator

National Cancer Institute

NCT07212712

/ Not yet recruitingNot ApplicableIIT

The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans

Due to historical exclusion of females from research, there are gaps in the understanding of female physiology, how it differs from males, and how sex-specific hormones contribute. As a result, many diagnoses and treatments are based on male physiology and may not be appropriate or effective for females. Females consistently experience greater risk and report worse neurological outcomes in many diseases, including stroke, cardiac arrest, and dementia. As research in females progresses, differences between sexes and changes throughout the lifespan (e.g., puberty, menopause) highlight the importance of understanding the effects of sex and sex-specific hormones on the body. The brain is arguably the most important organ in the body, consuming 20% of the body's total energy. Previous research supports higher blood flow to the brain in females, and research in animals suggests hormones such as estrogen, progesterone, and testosterone are responsible. However, it is extremely difficult to isolate these hormones in humans, due to natural fluctuations (i.e., menstrual cycle). Therefore, the investigators plan to explore the direct role of these sex-specific hormones in regulating blood flow to the brain by blocking hormone production in healthy males and females and giving back testosterone and estrogen, respectively. The investigators will then conduct a range of tests to look at blood flow to the brain at rest and during various stressors. This research will provide crucial insight into how males and females differ in regulation of brain blood flow and inform new treatments and therapies to a wide range of brain injuries and diseases, improving outcomes and reducing the sex disparity in clinical pathways.

Start Date01 Apr 2026

Sponsor / Collaborator

University of British Columbia

NCT06905301

/ 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 Date23 Jan 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Anastrozole

100 Translational Medicine associated with Anastrozole

100 Patents (Medical) associated with Anastrozole

2,820

Literatures (Medical) associated with Anastrozole

06 Feb 2026·Cancer Discovery

Giredestrant Delivers Long-Sought Adjuvant Benefit

Article

The oral selective estrogen receptor degrader giredestrant prolonged invasive disease-free survival more than standard endocrine therapies, such as tamoxifen, letrozole, anastrozole, and exemestane, in the phase III lidERA study. Despite the lack of comparisons between the drug and CDK4/6 inhibitors and concerns over its potential cost, researchers were excited by the data, noting that it’s the first improvement in adjuvant endocrine therapy in two decades.

01 Feb 2026·CANCER TREATMENT REVIEWS

Mechanisms and biomarkers for musculoskeletal signs and symptoms in patients treated with aromatase inhibitors: A comprehensive systematic review

Review

Author: Kellett, Catherine F ; Jatan, Noora ; Azar, Aida J ; Talo, Sami ; Adrian, Thomas E

BACKGROUND:

Aromatase inhibitors anastrozole and letrozole (non-steroidal, reversible), and exemestane (steroidal, irreversible) are approved standard therapies (Food and Drug Administration) for hormone receptor-positive breast cancer. Their use is limited by Aromatase Inhibitor-induced Musculoskeletal Signs and Symptoms (AIMSS).

METHODS:

Articles on AIMSS mechanisms and biomarkers published between January 1, 1990, and October 31, 2024, in PubMed, EMBASE, and Cochrane Library were identified. Included study designs were randomized and non-randomized trials, observational cohorts, cross-sectional studies, and preclinical animal models. Risk of bias was assessed using the Critical Appraisal Skills Programme tool for observational studies and Risk of Bias 2 for randomized trials.

RESULTS:

Fifty studies were included (43 human and seven animal). Estrogen deprivation was the central mechanism, affecting immune function, bone remodeling, and nociceptive sensitivity. Genetic variants in Estrogen Receptor 1, CYP19A1, and T-cell Leukemia/Lymphoma 1A were frequently associated with AIMSS. Vitamin D deficiency, polymorphisms in RANKL and Osteoprotegerin contributed to bone-related symptoms. Imaging studies identified tenosynovial thickening, tendon sheath fluid, and subclinical inflammation. Systemic inflammatory markers C-Reactive Protein and Interleukin 6 were elevated in human and animal studies. Transient Receptor Potential Ankyrin 1 and Transient Receptor Potential Vanilloid 4 ion channels were implicated in peripheral sensitization. Insulin-like Growth Factor 1 during AI therapy was independently associated with symptoms.

CONCLUSION:

AIMSS involves intersecting hormonal, genetic, inflammatory, and neural pathways. Identification of mechanistic biomarkers may support AIMSS risk stratification and targeted interventions. Further research should validate multi-omic models and explore new strategies to reduce AIMSS and improve treatment compliance.

REGISTRATION:

PROSPERO Registration: CRD42025642540.

01 Feb 2026·BIOMEDICAL CHROMATOGRAPHY

UHPLC Method Development for the Trace Level Quantification of Anastrozole and Its Process‐Related Impurities Using Design of Experiments

Article

Author: Pradhan, Subhalaxmi ; Pradhan, Gitanjali ; Yanamandra, Ramesh ; Tadisetty, Narasimha Rao

ABSTRACT:

A sensitive, selective, and robust ultra‐high‐performance liquid chromatography method was developed for the simultaneous quantification of anastrozole and five process‐related impurities at trace levels (≤ 0.1%). Traditional univariate optimization was replaced with a systematic chemometric approach using Box–Behnken Design to evaluate critical chromatographic parameters—mobile phase pH (3.0–4.0), column temperature (25°C–35°C), and flow rate (0.20–0.60 mL/min). Response Surface Methodology was employed to model retention behavior, resolution, and peak symmetry, with desirability function optimization identifying the ideal conditions (pH 3.20, 29.3°C, 0.33 mL/min). The method achieved baseline separation on an ACQUITY BEH C18 column (2.1 × 50 mm, 1.7 μm) using 10‐mM ammonium formate (pH‐adjusted) and acetonitrile as the mobile phase. Validation per International Council for Harmonisation Q2(R1) guidelines confirmed excellent linearity ( R2 ≥ 0.999), precision (%RSD ≤ 1.5% for ANZ; ≤ 5.3% for impurities), accuracy (recoveries: 94%–101%), and sensitivity (limit of detection: 0.011–0.014 μg/mL; limit of quantitation: 0.020–0.025 μg/mL). This study reports the first validated ultra‐high‐performance liquid chromatography method enabling trace‐level quantification of two newly identified (IMP‐1 and IMP‐2) and three previously reported process‐related impurities of anastrozole in a single run, using a Design of Experiments–based optimization approach.

News (Medical) associated with Anastrozole

20 Feb 2026

·www.biospace.com

FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer

Filing acceptance based on phase III data showing giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1 -mutated populations, respectively, versus standard-of-care endocrine therapy plus everolimus 1 Strength of evERA data demonstrate potential for giredestrant combination to help address resistance to standard-of-care therapies, and could be the first and only oral SERD combination approved in the post-CDK4/6 inhibitor setting 1 The FDA has set a Prescription Drug User Fee Act date of 18 December Basel, 20 February 2026 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1 -mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by 18 December 2026. Giredestrant plus everolimus could be the first and only oral selective oestrogen receptor degrader (SERD) combination approved in the post-cyclin-dependent kinase (CDK)4/6 inhibitor setting. “The clinically meaningful benefit seen with giredestrant could enable an important new treatment option to help delay disease progression or death in people with advanced, ER-positive breast cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This acceptance marks a first step towards establishing the giredestrant combination as a new standard of care in this population.” The filing acceptance is based on the phase III evERA Breast Cancer study results, which showed that giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in the intention-to-treat (ITT) and ESR1 -mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus. 1 In the ESR1 -mutated population, the median progression-free survival (PFS) was 9.99 months compared with 5.45 months in the giredestrant and comparator arm, respectively (stratified hazard ratio [HR]=0.38, 95% CI: 0.27-0.54, p-value=<0.0001). 1 In the ITT population, the median PFS was 8.77 months compared with 5.49 months in the giredestrant and comparator arms, respectively (HR=0.56, 95% CI: 0.44-0.71, p-value=<0.0001). 1 Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed in the ITT (HR=0.69, 95% CI: 0.47-1.00, p-value=0.0473) and ESR1 -mutated populations (HR=0.62, 95% CI: 0.38-1.02, p-value=0.0566). 1 Follow-up for OS will continue to the next analysis. Adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of the individual medicines. 1 No unexpected safety findings were observed, including no photopsia. 1 Data from evERA are being used to support filing submissions to other global health authorities. ER-positive breast cancer accounts for approximately 70% of breast cancer cases. 2 Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes. 2,3 Oral combination therapies, such as giredestrant plus everolimus, could address this by targeting two different signalling pathways while helping to minimise the impact of treatment on people’s lives without the need for injections. 4,5 evERA was the first positive phase III readout for giredestrant, followed by lidERA Breast Cancer in the early-stage setting. 1,6 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). 7 This growing body of evidence underscores the potential of giredestrant to become a new standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer. 1,6,7 In the coming weeks, Roche will submit the giredestrant phase III lidERA data in early-stage breast cancer to health authorities worldwide, including the FDA. The persevERA readout in first-line ER-positive breast cancer is expected in the first half of this year, which will provide further evidence for giredestrant in the ER-positive breast cancer treatment paradigm. Our extensive giredestrant clinical development programme 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 evERA Breast Cancer study evERA Breast Cancer [ NCT05306340 ] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard-of-care endocrine therapy in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting. 8 The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1 -mutated populations, defined as the time from randomisation to the time when the disease progresses or a patient dies from any cause. 8 The trial has been enriched for ESR1 -mutated patients above the natural prevalence to assess the efficacy in this population. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations. 9,10 Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety. 8 About giredestrant Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist. 11 Giredestrant is designed to block oestrogen from binding to the oestrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells. 12 Giredestrant has an extensive clinical development programme 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 ) 1 3 Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340 ) 7 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 ) 1 4 Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748 ) 1 5 Giredestrant plus Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798 ) 1 6 About oestrogen 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. 17 Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type. 18 ER-positive breast cancer accounts for approximately 70% of breast cancer cases. 2 A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth. 19 Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. 4 Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. 4,20 There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives. 4,20 About Roche in breast cancer Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes. By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer. About Roche 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. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Mayer E, et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial. Presented at: European Society for Medical Oncology (ESMO) Annual Meeting; 2025 October 17-21; Berlin, Germany. LBA #16. [2] Kinslow C, et al. Prevalence of Estrogen Receptor Alpha (ESR1) Somatic Mutations in Breast Cancer. JNCI Cancer Spectrum; 2022 Oct;6(5):pkac060. [3] Sahin T, et al. Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer. Cancer Treatment Reviews. 2025 April;135:102924. [4] Hanker A, et al. Overcoming Endocrine Resistance in Breast Cancer. Canc Cell. 2020 Apr 13;37(4):496–513. [5] Wood L. A review on adherence management in patients on oral cancer therapies. Eur J Oncol Nurs. 2012 Sept; 16(4):432-38. [6] Bardia A, et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global Phase III lidERA Breast Cancer trial. Presented at: San Antonio Breast Cancer Symposium (SABCS); 2025 December 9-12; San Antonio, Texas, United States. #GS1-10. [7] Hurvitz SA, et al. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023;24:1029–1041. [8] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) [Internet; cited 2026 February]. Available from: . [9] Meisel J L, et al. Real-world estrogen receptor 1 (ESR1) testing patterns and results in U.S. patients with metastatic breast cancer, 2018-2024. JCO Oncol Pract. 2025;21:579. [10] Chaudhary N, et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. npj Breast Cancer. 2024;10,15. [11] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: The ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO. [12] Metcalfe C, et al. GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. Presented at: SABCS; 2018 December 4-8; San Antonio, Texas, USA. Abstract #P5-04-07. [13] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) [Internet; cited 2026 February]. Available from: . [14] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) [Internet; cited 2026 February]. Available from: . [15] ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) [Internet; cited 2026 February]. Available from: . [16] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) [Internet; cited 2026 February]. Available from: . [17] World Health Organization. Breast Cancer [Internet; cited 2026 February]. Available from: . [18] World Health Organization. Cancer Today [Internet; cited 2026 February]. Available from: . [19] National Cancer Institute. Hormone Therapy for Breast Cancer [Internet; cited 2026 February]. Available from: . [20] Başaran G, et al. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer. Cancer Treat Rev. 2018 Feb;63:144-55. Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Nathalie Altermatt Phone: +41 79 771 05 25 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +49 172 6367262 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment Media & Investor Release evERA FDA Filing Acceptance English

Phase 3Clinical ResultPhase 2Drug Approval

13 Jan 2026

·www.globenewswire.com

Mapi Pharma is Seeking New Partnerships for Long-Acting Depot Drugs of Peptides for Self Administration

Jan. 06, 2026 -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative long-acting depot injectable treatments, will participate in the 44th Annual J.P. Morgan Healthcare Conference, to take place January 12-15, 2026, in San Francisco, California. Mapi is actively seeking new partnerships for its new proprietary Depot products. Company management will be available for one-on-one meetings during the J.P. Morgan Healthcare Conference to discuss potential joint development collaborations. Interested parties should contact Mapi directly. Mapi utilizes extended-release Depot technologies protected by strong IP to develop lifecycle Management products for innovative and existing commercially successful pharmaceuticals across multiple therapeutic areas. The Company currently has one partnered product covered under a commercialization agreement, GA Depot for Relapsing Forms of Multiple Sclerosis (RMS), and other products for diabetes and schizophrenia which are funded through Phase II results. The Company’s development pipeline also includes an injectable version of cariprazine, developed using Mapi’s Depot technology, which has demonstrated a long-acting release profile, for one monthly injection. It is designed to address an unmet need for patients with schizophrenia, bipolar I and major depression disorders. Mapi recently began enrolling patients in a Phase I/II study as described in ClinicalTrials.gov ID NCT07185815. Mapi is fully integrated in the development of Depot pharmaceuticals and offers partners multiple distinct technologies. The Company has an extensive R&D team with dedicated Depot labs, an experienced clinical team, as well as a large-scale, state-of-the-art GMP approved manufacturing facility for both clinical development and commercial supply. Mapi has the capabilities to efficiently develop Depot products by integrating R&D, clinical studies, registration and manufacturing and has a successful track record of improving time to market. Ehud Marom, Chairman and Chief Executive Officer, Mapi Pharma, said, “We have a number of compelling partnering opportunities in our current pipeline, including Deutetrabenazine (AUSTEDO® XR) Depot for the treatment of Huntington's disease and tardive dyskinesia, and Anastrazole (Arimidex®) Depot as an adjuvant treatment for postmenopausal women with hormone receptor-positive early breast cancer, as well as other candidates. We are seeking to apply our technologies to co-develop Depot drugs with companies that are interested in developing long-acting injectable lifecycle management products." Mapi Pharma (Mapi) is a clinical stage pharmaceutical company, engaged in development of high barrier-to-entry and high added-value life cycle management ("LCM") products and AB Rated Depot injectable products that target large markets that include complex active pharmaceutical ingredients ("APIs") and formulations. Mapi’s lead product is GA Depot which is partnered with Viatris (NASDAQ: VTRS) in an agreement under which Viatris was granted an exclusive license to commercialize the GA Depot injection product for Relapsing Forms of Multiple Sclerosis (RMS). Following successful Phase 3 results GA Depot is currently under FDA review. The Company is also marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in specific geographic markets. Mapi's portfolio also includes a leading development of Depot drugs for Schizophrenia, GLP-1 for diabetes, weight loss, with innovative intellectual property. Mapi is built on strong chemical and pharmaceutical R&D and clinical development capabilities and a deep understanding of the global market and of regulatory needs. Mapi is a global company with an API production and aseptic Depot manufacturing and a Fill & Finish for injectable Finished Dosage Forms facilities. Mapi has strong IP positions, filing numerous patent applications for APIs and formulations. For more information, please visit www.mapi-pharma.com The content above comes from the network. if any infringement, please contact us to modify.

License out/in

16 Dec 2025

·www.drugs.com

SABCS: New Endocrine Therapy, Giredestrant, Cuts Breast Cancer Recurrence

TUESDAY, Dec. 16, 2025 – Giredestrant, a selective estrogen receptor antagonist and degrader given as an adjuvant therapy, shows significant improvement in invasive disease-free survival (iDFS) in patients with early-stage, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer , according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio. Aditya Bardia, M.D., M.P.H., from the University of California Los Angeles, and colleagues conducted a global, randomized, open-label trial in which 4,170 patients with HR-positive, HER2-negative early breast cancer (stages I to III) were assigned (1:1) to receive either 30 mg of oral giredestrant daily or one of four standard-of-care endocrine therapies (tamoxifen, letrozole, anastrozole, or exemestane). All patients received surgery and, if indicated, completed adjuvant or neoadjuvant chemotherapy. The researchers report that after a median follow-up of 32.3 months, patients who received giredestrant had significantly better iDFS than those receiving standard-of-care endocrine therapy and were 30 percent less likely to develop invasive disease progression at follow-up. Additionally, patients who received giredestrant were 31 percent less likely than those in the standard-of-care arm to experience distant recurrence at follow-up. Overall survival data were immature but showed a positive trend in favor of giredestrant. "Giredestrant demonstrated clinically meaningful superiority to currently well-established standard-of-care endocrine agents: aromatase inhibitors and tamoxifen," Bardia said in a statement. "What is particularly striking and relevant is early separation of [the overall survival] curves." Several authors disclosed financial ties to pharmaceutical companies, including F. Hoffmann-La Roche, which manufactures giredestrant and funded the study. Press Release More Information

Clinical Result

100 Deals associated with Anastrozole

External Link

KEGG	Wiki	ATC	Drug Bank
D00960	Anastrozole	L02BG03	DB01217

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	Phase 3	Spain	AstraZeneca AB	23 Sep 2021
Premenopausal breast cancer	Phase 3	Japan	AstraZeneca PLC	01 Oct 2007
Solitary Fibrous Tumors	Phase 3	France	AstraZeneca AB	31 Oct 2006
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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04272801 (POWER, CTgov)	Phase 2	Early Stage Breast Carcinoma	84	Patient reported outcomes+letrozole+tamoxifen+exemestane+anastrozole	qjnocymtma = gugumiimok dkbcdpzykt (monvckbjhx, fkiyjvvgtd - djfxqbaxps) View more	-	22 Oct 2025
NCT02206984 (TBCRC037, ESMO2025)	-	Hormone receptor negative HER2 positive breast cancer hormone receptor-positive \| HER2-negative	172	Fulvestrant	cbrqimtgjc(hsahxojqbj): P-Value = 0.042	Positive	17 Oct 2025
				Tamoxifen
NCT00253422 (SoFEA, CTgov)	Phase 3	Breast Cancer	698	fulvestrant+anastrozole (Faslodex + Placebo)	ptahngldog(qktwkqmkvi) = wgqzgzwleb senlabpuba (lyndkrfowq, qztoltlwgy - liwzymhkbv) View more	-	04 Jun 2025
				fulvestrant+anastrozole (Faslodex + Arimidex)	ptahngldog(qktwkqmkvi) = tkettrosah senlabpuba (lyndkrfowq, jyewmwoyqq - cfeqszjaxb) View more
NCT04294225 (CTgov)	Phase 2	Invasive Mammary Carcinoma \| Early Stage Breast Carcinoma	161	Letrozole+anastrozole	cmdnmqezar = zazbzrokxy fnppxndnri (niezlwmbsh, wbmuzlwtoz - wlaaaemzsn) View more	-	28 Jan 2025
ESPE2024	Not Applicable	Idiopathic short stature	105	Letrozole combined with rhGH	hqnvnwxuqe(hlvdumjwtr) = ayhfgfpgfu fapdukwibe (mkpgnjcyel, 0.32) View more	Positive	16 Nov 2024
				Anastrozole combined with rhGH	hqnvnwxuqe(hlvdumjwtr) = etqypxidqv fapdukwibe (mkpgnjcyel, 0.4) View more
NCT00072462 (IBIS-II DCIS, CTgov)	Phase 3	Ductal Carcinoma \| Breast Cancer \| Noninfiltrating Intraductal Carcinoma	2,980	anastrozole (Anastrozole)	auwwoordub = mcrxtrkvdk xjcypbbnwy (jicpqwuqha, boeizlinqw - bopfjruvxf) View more	-	19 Sep 2024
				tamoxifen citrate (Tamoxifen)	auwwoordub = mlalbsngdg xjcypbbnwy (jicpqwuqha, gdurewezbw - oeqinhryes) View more
NCT03229499 (PHANTOM, Pubmed \| Am J Respir Crit Care Med) Manual	Phase 2	Hypertension, Pulmonary post-menopausal	84	Anastrozole 1 mg	lqbemcizbm(hhlngtodkx) = lnicbnxshn tpcbnsvtqo (doewgvvcaw, -32.7 to 16.9)	Negative	15 May 2024
NCT03229499 (PHANTOM, CTgov)	Phase 2	Pulmonary Arterial Hypertension	84	anastrozole (Anastrozole)	mlxgwhinxd(hrpniryykd) = lvgmzdlvzc zffycdmflm (ahabduxlvv, kuqeoxvkiu - ovrtxgyojz) View more	-	01 May 2024
				Placebo Oral Tablet (Placebo)	mlxgwhinxd(hrpniryykd) = tmfxkkwlls zffycdmflm (ahabduxlvv, bmaqxmbkii - rtdgvktfcj) View more
NCT03822468 (AMALEE, CTgov)	Phase 2	Advanced cancer \| Hormone receptor positive HER2 negative breast cancer	376	Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 400 mg)	proiumnumj = frkvkbtccj stvkmeftec (dxnaqvtidl, yfybbqppnn - ctoziofdti) View more	-	05 Apr 2024
				Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 600 mg)	proiumnumj = xdfjsdmwoq stvkmeftec (dxnaqvtidl, jyleyyqfmp - kpijeuiuzt) View more
NCT00295646 (ABCSG-12, CTgov)	Phase 3	Hormone receptor positive breast cancer	1,803	zoledronic acid+goserelin+anastrozole (AZ (Arimidex+Zoledronate))	mdwlvgakhs(cseznnzrif) = vutasdmpgp rwsbuacxvu (yxerzwjigy, hzkgxapvrj - mowhyfadfa) View more	-	15 Mar 2024
				tamoxifen+zoledronic acid+goserelin (TZ (Tamoxifen+Zoledronate))	mdwlvgakhs(cseznnzrif) = afmdinoivt rwsbuacxvu (yxerzwjigy, nbphkmynvz - rddrcovoap) View more

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