Camizestrant: Camizestrant will be administered orally.
Atirmociclib: Atirmociclib will be administered orally.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with adverse events (AEs) and serious AEs — Up to Post-Treatment Follow up (Day 30 Post Dose) To investigate the safety and tolerability of camizestrant in combination with atirmociclib.
Trial sites (6)
Facility
City
Region
Status
Research Site
St Louis
Missouri
Recruiting
Research Site
East Providence
Rhode Island
Not Yet Recruiting
Research Site
Nashville
Tennessee
Recruiting
Research Site
Cambridge
United Kingdom
Recruiting
Research Site
London
United Kingdom
Recruiting
Research Site
Manchester
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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