Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in… (NCT07427394) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
United States, United Kingdom24 participantsStarted 2026-04-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main 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.…
What they're measuring
1
Number of participants with adverse events (AEs) and serious AEs
Timeframe: Up to Post-Treatment Follow up (Day 30 Post Dose)