Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

Phase 2RecruitingNCT07427394

AstraZeneca24 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Breast Cancer

Interventions

CamizestrantDRUG

Camizestrant will be administered orally.

AtirmociclibDRUG

Atirmociclib will be administered orally.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Research Site

St Louis, Missouri, United States

NOT_YET_RECRUITING

Research Site

East Providence, Rhode Island, United States

NOT_YET_RECRUITING

Research Site

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs) and serious AEs

To investigate the safety and tolerability of camizestrant in combination with atirmociclib.

Time frame: Up to Post-Treatment Follow up (Day 30 Post Dose)