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Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer | Clinical Trials | Clareo Health

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Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

NCT07427394•AstraZeneca

View on ClinicalTrials.gov

Summary

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

Detailed Description

This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib. The single-arm study includes: * Screening period * Atirmociclib single dose period * Doublet intervention period * Post-treatment follow-up period

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.
•Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.
•Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.
•At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.
•Menopausal status
•* Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.
•* Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age \<60 years with ≥12 months amenorrhea and post-menopausal hormone levels.
•Histological or cytological confirmation of adenocarcinoma of the breast.
•Participants of childbearing potential must agree to use one highly effective contraceptive measure.
•Documentation of ER-positive tumor irrespective of progesterone receptor status.

Exclusion Criteria

•A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting.
•A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.
•Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.
•Inability to swallow oral medications.
•Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).
•Presence of life-threatening metastatic visceral disease.
•Any evidence of severe or uncontrolled systemic diseases.
•Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.

Locations (6)

Research Site

St Louis, Missouri, United States

Research Site

East Providence, Rhode Island, United States

Research Site

Nashville, Tennessee, United States

Research Site

Cambridge, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

Key Dates

Start Date

April 10, 2026

Primary Completion Date

December 3, 2027

Completion Date

December 3, 2027

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Breast Cancer

Interventions

Camizestrant

DRUG

Atirmociclib

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

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