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

ArmDescriptionAssigned 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.
  • Drug: Camizestrant
    Camizestrant will be administered orally.
  • Drug: Atirmociclib
    Atirmociclib will be administered orally.

Recruiting Locations

Research Site
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
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