Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in… (NCT07427394) | Clinical Trial Compass
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 2026-05-06
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 range
18 Years
Sex
FEMALE
See this in plain English?
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.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial focused on safety and tolerability — what does that mean for what we'd actually know about whether camizestrant combined with atirmociclib is working against my cancer, versus just whether it's safe to take?
2Since the primary goal of this study is tracking adverse events and serious adverse events, what kinds of side effects have been seen with either of these drugs individually, and what could combining them potentially add to that risk?
3How does my current health status and any prior treatments I've had affect whether I might be a candidate worth discussing for this trial with my care team?
4Are there already approved or standard treatment options for advanced breast cancer in my situation that I should consider before exploring an experimental combination like this one?
5What would my treatment schedule and monitoring look like if I were to participate — how often would I need to come in for safety checks, and how might that fit into my daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)