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Study of Camizestrant and Atirmociclib for Advanced Breast Cancer

This study is looking at the safety and how well two oral medicines, camizestrant and atirmociclib, work together for women with advanced breast cancer. You might be able to join if you have advanced breast cancer that is estrogen receptor (ER)-positive and HER2-negative, and has grown after previous treatment with a CDK4/6 inhibitor. The main goal is to see how many participants experience side effects (adverse events) and serious side effects. The study aims to enroll 24 women. This research will help doctors understand if this combination treatment is safe and tolerable.

Study design
This is a Phase IIa, single-arm, open-label study, meaning all participants will receive the study drugs and everyone involved will know which treatments are being given. It plans to enroll 24 women.
What's involved
The study involves a screening period, a period where you take atirmociclib alone, a period where you take both camizestrant and atirmociclib, and a follow-up period after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up to 30 days after their last dose of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07427394

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~24 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:CamizestrantAtirmociclib

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs) and serious AEs
Measured over Up to Post-Treatment Follow up (Day 30 Post Dose)

Conditions

Advanced Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

6 sites across 4 states
United Kingdom3
Missouri1
Rhode Island1
Tennessee1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.
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.

What this trial measures

  • Number of participants with adverse events (AEs) and serious AEsUp to Post-Treatment Follow up (Day 30 Post Dose)

    To investigate the safety and tolerability of camizestrant in combination with atirmociclib.