A Phase IIIb Study to Characterize the Effectiveness and Safety of Adjuvant Ribociclib in a Wide Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

An open-label, multicenter, phase IIIb, single-arm study to evaluate the safety and efficacy of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a wide patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, II (subset) or I (high-risk subset as exploratory cohort) early Breast Cancer (EBC)

Start Date20 Apr 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT06223698

/ Not yet recruitingPhase 3IIT

Optimizing Extended Adjuvant Endocrine Therapy in Patients with Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial

Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice.
The primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios:
* In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen.
* In postmenopausal women at diagnosis.

Start Date02 Jan 2025

Sponsor / Collaborator

Uppsala University Hospital

CTR20244051

/ Active, not recruitingNot Applicable

阿那曲唑片人体生物等效性研究

[Translation] Study on the bioequivalence of anastrozole tablets in healthy volunteers

本试验旨在研究单次空腹和餐后口服海南日中天制药有限公司研制、生产的阿那曲唑片（1 mg）的药代动力学特征；以AstraZeneca Pharmaceuticals LP生产的阿那曲唑片（瑞宁得®，1 mg）为参比制剂，比较两制剂中药动学参数Cmax和AUC0-72，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of anastrozole tablets (1 mg) developed and produced by Hainan Rizhongtian Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using anastrozole tablets (Arimidex®, 1 mg) produced by AstraZeneca Pharmaceuticals LP as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

Start Date27 Nov 2024

Sponsor / Collaborator

Hainan Rizhongtian Pharmaceutical Co., Ltd.

100 Clinical Results associated with Anastrozole

100 Translational Medicine associated with Anastrozole

100 Patents (Medical) associated with Anastrozole

3,428

Literatures (Medical) associated with Anastrozole

01 May 2025·MODERN PATHOLOGY

Frank Invasion in Tall Cell Carcinoma With Reversed Polarity of the Breast: Report of Two Cases

Article

Author: Ross, Dara S ; Han, Rachel ; Wen, Hannah Y ; Brogi, Edi ; Pareja, Fresia ; Grabenstetter, Anne

Tall cell carcinoma with reversed polarity (TCCRP) is a rare neoplasm of the breast composed of columnar tumor cells arranged in solid and solid papillary nests with evidence of apical nuclear polarity. No frank invasion is evident despite the lack of a myoepithelial cell layer throughout the tumor. TCCRP has a triple negative or hormone receptor-low immunophenotype. Recurrent IDH2 R172 hotspot mutation coexisting with genetic alterations in the PI3K pathway characterize this tumor. Here, we report on two postmenopausal patients with TCCRPs with frank stromal invasion. IDH2 R172 mutations were detected in both tumors by immunohistochemistry. Targeted sequencing of case 2 demonstrated the presence of IDH2 R172T and RTEL1 E839K mutations. Both patients underwent breast conservation surgery, radiation therapy and adjuvant endocrine therapy with anastrozole and show no evidence of disease at 65 and 25 months, respectively. This study suggests that tall cell carcinoma with reversed polarity may give rise to frank invasive carcinoma, the prognostic significance of which is yet unknown.

01 Mar 2025·NEUROPHARMACOLOGY

Neuroprotective effects of testosterone on sevoflurane-induced neurotoxicity in testosterone-deprived male mice

Article

Author: Long, Siwen ; Li, Dujuan ; Yu, Yonghao ; Li, Feixiang ; Yu, Jiafeng ; Yang, Yue ; Yang, Yongyan ; Gong, Bingqing

This study aims to investigate whether androgen deprivation, simulating conditions of aging or disease-induced low testosterone levels, increases the susceptibility of male mice to sevoflurane neurotoxicity, and whether testosterone supplementation can reverse the toxic effects of sevoflurane. In here, young male mice were subjected to orchiectomy (ORC) to induce testosterone deprivation. Various techniques, including western blotting, immunofluorescence, Morris Water Maze, Golgi staining, and neuronal signal measurement, were used to evaluate the effects of sevoflurane on long-term (ORC 10 weeks) and short-term (ORC 2 weeks) testosterone deprivation, and assess whether testosterone (1 mg/kg 1 h before sevoflurane exposure) could mitigate sevoflurane-induced neurotoxicity. Flutamide and anastrozole were administered to study testosterone's pathways of action. We found that sevoflurane increased tau phosphorylation and decreased the transient amplitude of Ca²⁺ signals and dendritic spine density in dorsal hippocampal CA1 (dCA1) neurons, leading to cognitive impairment in testosterone-deprived male mice. Testosterone treatment reversed the effects of sevoflurane in short-term testosterone-deprived male mice, but not in long-term testosterone-deprived male mice. Additionally, the neuroprotective effect of testosterone was blocked by flutamide rather than anastrozole. We have discovered for the first time that testosterone can mitigate the sevoflurane-induced neurotoxicity in testosterone-deprived male mice and that there exists a therapeutic time window, which may be mediated by androgen receptors. This may provide new insights into the neuroprotective role of sex hormones.

01 Mar 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Three sample preparation methods for clinical determination of CDK4/6 inhibitors with endocrine therapy in breast cancer patient plasma using LC-MS: Cross-validation (red), ecological (green) and economical (blue) assessment

Article

Author: Mlinarić, Zvonimir ; Turković, Lu ; Sertić, Miranda ; Lovrić, Mila ; Silovski, Tajana ; Nigović, Biljana

Cyclin D-dependent kinase 4/6 inhibitors palbociclib, ribociclib and abemaciclib, in combination with aromatase inhibitors anastrozole and letrozole or oestrogen receptor degrader fulvestrant, are being assessed as candidates for therapeutic drug monitoring. An ideal bioanalytical method for their determination in patient plasma samples is therefore of high interest, as there is no routine reference method yet available in the clinical practice. In this work, three sample preparation approaches - dispersive liquid-liquid microextraction (DLLME), solid-phase extraction (SPE), and newly developed phospholipid removal (PLR) for LC-MS determination of these six drugs are comprehensively assessed. The methods are validated in the clinically relevant linear ranges with remarkable precision (RSD ≤6.9 %) and accuracy (bias -13.6 - 11.8 %). To compare the procedures in a real-world setting, they are applied on 38 samples from breast cancer patients. The differences between paired results are below 20 % for more than 92 % of the repeats and the RSD is ≤13.1 % between the corresponding results. Statistical comparison of the results reveals excellent overall agreement between the methods (Lin's concordance correlation coefficient ≥0.9969, maximal Bland-Altman bias 6.3 %). DLLME proved to be the most ecologically acceptable method due to the high degree of miniaturisation (AGREEprep score 0.44), PLR enabled very high sample throughput and cost-effectiveness (BAGI 72.5), while SPE showed the best analytical performance (redness score 100). All three methods are suitable for their designated purpose, and the choice of the ideal method can be made based on the scope of application, available funds and equipment and desired ecological footprint.

News (Medical) associated with Anastrozole

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

26 Feb 2025

·pipelinereview.com

Camizestrant demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival in 1st-line advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial

First and only next-generation oral SERD and complete ER antagonist to demonstrate 1st-line benefit in combination with widely approved CDK4/6 inhibitors LONDON, UK I February 26, 2025 I Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation. The key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of this interim analysis. However, the camizestrant combination demonstrated a trend toward improvement in PFS2. The trial will continue as planned to further assess key secondary endpoints. SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The novel trial design used ctDNA monitoring at the time of routine tumour scan visits to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor. François-Clément Bidard, MD, PhD, Professor of Medical Oncology at Institut Curie & UVSQ/Université Paris-Saclay, France, and co-principal investigator for the trial, said: “Patients have an urgent need for new treatments that delay disease progression on 1st-line endocrine-based therapies. The results from SERENA-6 show that switching from an aromatase inhibitor to camizestrant in combination with any of the three CDK4/6 inhibitors after emergence of an ESR1 mutation delays progression of disease and extends the benefit of 1st-line treatment, representing an important step forward for patients, and a potential shift in clinical practice.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “These impressive results demonstrate the versatility of camizestrant in combination with all the widely approved CDK4/6 inhibitors to provide a well-tolerated new potential treatment option in the first-line setting for the one in three patients with HR-positive, HER2-negative advanced breast cancer whose tumours develop ESR1 mutations during treatment with an aromatase inhibitor in combination with a CDK4/6 inhibitor. This critical read-out moves us one step closer to realising the potential of camizestrant to become a new standard-of-care as we look to shift the treatment paradigm and establish this new endocrine therapy backbone in HR-positive breast cancer.” The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in SERENA-6 was consistent with the known safety profile of each medicine. No new safety concerns were identified and discontinuations were very low and similar in both arms. Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target estrogen receptor (ER)-driven disease, which are often paired with CDK4/6 inhibitors. 1-3 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 3 Mutations in the ESR1 gene are a key driver of endocrine resistance and are widely tested for in clinical practice. 4,5 Thesemutations develop during treatment of the disease, becoming more prevalent as the disease progresses and are associated with poor outcomes. 4,5 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment without disease progression. 1 Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Notes HR-positive breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 6 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally. 6 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 7 HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative. 7 ERs often drive the growth of HR-positive breast cancer cells. 8 Once resistance to the treatment of HR-positive breast cancer with CDK4/6 inhibitors and current endocrine therapies occurs, treatment options are limited and survival rates are low with 35% of patients anticipated to live beyond five years after diagnosis. 3,7,9 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research. SERENA-6 SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib ) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation. The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment. Camizestrant Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer. AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with other agents to address a number of areas of unmet need in this specific type of breast cancer. Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated PFS benefit versus Faslodex (fulvestrant) irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors. Combinations with other agents are ongoing in SERENA-1. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu (trastuzumab deruxtecan), a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease. AstraZeneca is also exploring the efficacy and safety of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @ AstraZeneca . Contacts For details on how to contact the Investor Relations Team, please click here . For Media contacts, click here . References SOURCE: AstraZeneca

Clinical ResultPhase 3Phase 2Phase 1

26 Feb 2025

·www.drugs.com

Camizestrant Demonstrated Highly Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in 1st-Line Advanced HR-Positive Breast Cancer with an Emergent ESR1 Tumor Mutation in SERENA-6 Phase III Trial

26 February 2025 -- Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation. The key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of this interim analysis. However, the camizestrant combination demonstrated a trend toward improvement in PFS2. The trial will continue as planned to further assess key secondary endpoints. SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The novel trial design used ctDNA monitoring at the time of routine tumour scan visits to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor. François-Clément Bidard, MD, PhD, Professor of Medical Oncology at Institut Curie & UVSQ/Université Paris-Saclay, France, and co-principal investigator for the trial, said: “Patients have an urgent need for new treatments that delay disease progression on 1st-line endocrine-based therapies. The results from SERENA-6 show that switching from an aromatase inhibitor to camizestrant in combination with any of the three CDK4/6 inhibitors after emergence of an ESR1 mutation delays progression of disease and extends the benefit of 1st-line treatment, representing an important step forward for patients, and a potential shift in clinical practice.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "These impressive results demonstrate the versatility of camizestrant in combination with all the widely approved CDK4/6 inhibitors to provide a well-tolerated new potential treatment option in the first-line setting for the one in three patients with HR-positive, HER2-negative advanced breast cancer whose tumours develop ESR1 mutations during treatment with an aromatase inhibitor in combination with a CDK4/6 inhibitor. This critical read-out moves us one step closer to realising the potential of camizestrant to become a new standard-of-care as we look to shift the treatment paradigm and establish this new endocrine therapy backbone in HR-positive breast cancer.” The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in SERENA-6 was consistent with the known safety profile of each medicine. No new safety concerns were identified and discontinuations were very low and similar in both arms. Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target estrogen receptor (ER)-driven disease, which are often paired with CDK4/6 inhibitors. 1-3 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 3 Mutations in the ESR1 gene are a key driver of endocrine resistance and are widely tested for in clinical practice. 4,5 These mutations develop during treatment of the disease, becoming more prevalent as the disease progresses and are associated with poor outcomes. 4,5 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment without disease progression. 1 Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 3

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	US	Astrazeneca Plc /Plankstadt Plant/	05 Dec 2008
Gynecomastia	US	Astrazeneca Plc /Plankstadt Plant/	05 Dec 2008
Breast Cancer	JP	AstraZeneca KK	22 Dec 2000
Metastatic breast cancer	US	ANI Pharmaceuticals, Inc.	01 Sep 2000
Advanced breast cancer	AU	AstraZeneca Pty Ltd.	17 Dec 1996
Early Stage Breast Carcinoma	AU	AstraZeneca Pty Ltd.	17 Dec 1996
Locally advanced breast cancer	US	ANI Pharmaceuticals, Inc.	27 Dec 1995

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Premenopausal breast cancer	Phase 3	JP	AstraZeneca PLC	01 Oct 2007
Breast cancer recurrent	Phase 3	JP	Pfizer Inc.	01 Apr 2005
Growth hormone deficiency	Phase 3	US	AstraZeneca PLC	01 Nov 2001
Estrogen receptor positive breast cancer	Phase 3	US	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	JP	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	BE	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	BR	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	CA	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	CZ	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	FR	AstraZeneca PLC	01 Aug 2000

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04294225 (CTgov)	Phase 2	Neutropenia \| Invasive Mammary Carcinoma \| Early Stage Breast Carcinoma	161	Letrozole+anastrozole	tbjywiscwx(ypvrswbgbf) = fhpkgqvnqd upashyrcak (wobgdduqsb, epbvvvpdhu - xuyulwjlej) View more	-	28 Jan 2025
NCT00072462 (IBIS-II DCIS, CTgov)	Phase 3	Ductal Carcinoma \| Breast Cancer \| Noninfiltrating Intraductal Carcinoma	2,980	anastrozole (Anastrozole)	amabzxtgnx(aeiolgsvpf) = esovcvogpf gccyyzsunt (gkgnicxeto, iyjaihduov - fzsvflttvw) View more	-	19 Sep 2024
				tamoxifen citrate (Tamoxifen)	amabzxtgnx(aeiolgsvpf) = qlgaqxpbjf gccyyzsunt (gkgnicxeto, uscyqhuocw - ptvtamqmbc) View more
NCT03229499 (PHANTOM, Pubmed \| Am J Respir Crit Care Med) Manual	Phase 2	Hypertension, Pulmonary post-menopausal	84	Anastrozole 1 mg	goibahiaex(hvuktyqnyv) = emgkzcbhsw edfydqqrxi (putlsbcplo, -32.7 to 16.9)	Negative	15 May 2024
NCT03229499 (PHANTOM, CTgov)	Phase 2	Pulmonary Arterial Hypertension	84	anastrozole (Anastrozole)	irfhhjoesd(yxagjylrmv) = qobvlgbuik nobdyuiljv (xplsuqkygt, tuqzjtkrad - gppxjtedow) View more	-	01 May 2024
				Placebo Oral Tablet (Placebo)	irfhhjoesd(yxagjylrmv) = whsyxmgcik nobdyuiljv (xplsuqkygt, mvnxoqqzws - letoobypwf) View more
NCT03822468 (AMALEE, CTgov)	Phase 2	Advanced cancer \| Hormone receptor positive HER2 negative breast cancer	376	Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 400 mg)	dixfbdhtfm(cfpsophlrb) = kyoucgsqjo vvoffshpxp (bfuhxairqj, yzgxpuliwg - ywcuqokxzw) View more	-	05 Apr 2024
				Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 600 mg)	dixfbdhtfm(cfpsophlrb) = rpfaywiyqj vvoffshpxp (bfuhxairqj, dgwcnnggbr - gweatedbfa) View more
NCT00295646 (ABCSG-12, CTgov)	Phase 3	Hormone receptor positive breast cancer	1,803	goserelin+zoledronic acid+anastrozole (AZ (Arimidex+Zoledronate))	aswfzcvhtj(myjrjivrjq) = vvpkwkvhke nvnakypcdj (abffygjsjk, pfwjjixviw - islemzhser) View more	-	15 Mar 2024
				goserelin+Tamoxifen+zoledronic acid (TZ (Tamoxifen+Zoledronate))	aswfzcvhtj(myjrjivrjq) = aiydwpapco nvnakypcdj (abffygjsjk, keuswrfwni - xahcrgdhvv) View more
NCT01953588 (Pubmed)	Phase 3	Estrogen receptor-negative breast cancer Neoadjuvant Ki67	1,362	Anastrozole	herrslyrbk(ymimerdqau) = mniejefkjr zhcwinggth (xanmrjrhup, 15.1 - 22.7)	-	18 Jan 2024
				Fulvestrant	herrslyrbk(ymimerdqau) = tmczyvjrzg zhcwinggth (xanmrjrhup, 18.9 - 27.1)
NCT03481998 (phase Ib, Pubmed \| Ther Adv Med Oncol)	Phase 1	HR Positive/HER2 Negative/Node positive breast cancer HR-positive \| HER2-negative	-	Dalpiciclib 125 mg	xjyqlsxiyf(lmkzordbpa) = mwdghvpeoy yeghzblsva (vylijeewlf ) View more	Positive	01 Jan 2024
				Dalpiciclib 150 mg	xjyqlsxiyf(lmkzordbpa) = ytmjeyvnry yeghzblsva (vylijeewlf ) View more
NCT01674140 (S1207 \| SWOG S1207 \| e3, CTgov)	Phase 3	Hormone receptor positive HER2 negative breast cancer	1,939	placebo+letrozole+tamoxifen citrate+exemestane+leuprolide acetate+goserelin acetate+anastrozole (Placebo)	lpvtprqxhy(tqlqbdferl) = zbbsvopvnc titkzoocgg (fsheumbpcr, ogcpmohazt - dxchfqtepm) View more	-	20 Dec 2023
				Everolimus (Everolimus)	lpvtprqxhy(tqlqbdferl) = ipoghqygjg titkzoocgg (fsheumbpcr, gzzzgeavjm - gaoyxldofl) View more
AASLD2023	Not Applicable	Breast Cancer	233	No hormone therapy	qrflvcyigf(ygakgeekyd) = tgpqmxnpqa hbpbethmhn (xpjqejcynp ) View more	-	10 Nov 2023
				Anastrozole	qrflvcyigf(ygakgeekyd) = xrehvnblaw hbpbethmhn (xpjqejcynp ) View more

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