Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07427394
Eligibility Criteria:
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.
Main 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.
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07427394
Study Brief:
Protocol Section:
NCT07427394