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anastrozole

Generic: ANASTROZOLE·Brand: ANASTROZOLE, ARIMIDEX, Arimidex

anastrozole: developed by 1 company · 33 clinical trials tracked · 1 FDA decision.

anastrozole evidence translation

What we can confirm

1 FDA record · 33 tracked trials

What it means

Source-backed records connect anastrozole to AZN; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could anastrozole → AZN affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence7 indications · 12 study sponsors
Development Pipeline (1)
CompanyPhase
ASTRAZENECA PLC (AZN)
Hormone Receptor Positive Breast Cancer
Phase 3
Clinical Trials (33)showing 10 most recent

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

NCT07391774·Phase 3·MRUS
Not yet recruiting

Primary endpoint: Invasive breast cancer-free survival (iBCFS)

InterventionalRandomizedopen1,978 targetStarted 2026-07Completion 2029-07National Cancer Institute (NCI)

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

Recruiting

Primary endpoint: Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period

Observational240 targetStarted 2026-01Completion 2029-127 sites · RussiaNovartis Pharmaceuticals

A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

NCT07174336·Phase 3·LLY
Recruiting

Primary endpoint: (Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)

InterventionalRandomizeddouble800 targetStarted 2025-12Completion 2033-0550 sites · United StatesEli Lilly and Company

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

Recruiting

Primary endpoint: Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort

Observational2,766 targetStarted 2025-12Completion 2032-1242 sites · RussiaNovartis Pharmaceuticals

LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients With Molecular Low-Risk Early-Stage Breast Cancer

NCT06671912·Phase 3
Suspended

Primary endpoint: Recurrence-free interval (RFI)

InterventionalRandomizedopen1,556 targetStarted 2025-02Completion 2031-1150 sites · United StatesAlliance for Clinical Trials in Oncology

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

NCT06492616·Phase 3·RANI
Recruiting

Primary endpoint: Invasive Breast Cancer-Free Survival (IBCFS)

InterventionalRandomizedopen4,220 targetStarted 2024-09Completion 2032-1050 sites · United StatesStemline Therapeutics, Inc.

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

NCT06380751·Phase 3·AZN
Recruiting

Primary endpoint: Progression-Free Survival (Arm 1 vs arm 2)

InterventionalRandomizedopen788 targetStarted 2024-08Completion 2031-1250 sites · United StatesAstraZeneca

A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

NCT06072781·Phase 3·VSTM
Recruiting

Primary endpoint: Progression Free Survival (PFS) per blinded independent central review (BICR)

InterventionalRandomizedopen270 targetStarted 2024-03Completion 2031-0250 sites · Australia, Belgium, Canada, Denmark…Verastem, Inc.

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse

NCT05512364·Phase 3·GHRS
Recruiting

Primary endpoint: Distant metastasis free survival (DMFS)

InterventionalRandomizedopen220 targetStarted 2023-12Completion 2035-1150 sites · Belgium, Cyprus, France, Germany…European Organisation for Research and Treatment of Cancer - EORTC

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

NCT06016738·Phase 3·OLMA
Active, not recruiting

Primary endpoint: Dose-Selection Part: Incidence of adverse events

InterventionalRandomizedopen510 targetStarted 2023-11Completion 2028-0250 sites · Argentina, United StatesOlema Pharmaceuticals, Inc.
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 ) • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients (AZN)FDA ↗
NDA022214Type 6 - New Indication (no longer used)PriorityOralTablet

Frequently asked questions

Who is developing anastrozole?

anastrozole is being developed by ASTRAZENECA PLC.

How many clinical trials involve anastrozole?

BioSniper tracks 33 clinical trials involving anastrozole.

What is anastrozole's latest FDA decision?

The most recent tracked FDA decision for anastrozole is Approval for 1 INDICATIONS AND USAGE ARIMIDEX is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 ) • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients , dated December 5, 2008.