Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
Purpose
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.
Condition
- Advanced Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Camizestrant + Atirmociclib |
Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1. |
|
Recruiting Locations
Research Site
Nashville, Tennessee 37203
Nashville, Tennessee 37203
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed Description
This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib. The single-arm study includes: - Screening period - Atirmociclib single dose period - Doublet intervention period - Post-treatment follow-up period