Study on Saruparib and Camizestrant Compared to Other Treatments for Advanced HR-Positive, HER2-Negative Breast Cancer with BRCA1, BRCA2, or PALB2 Mutations

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06380751

Provider View

This clinical trial is testing the effectiveness of a new drug combination, Saruparib and Camizestrant, compared to other standard treatments for patients with advanced HR-positive, HER2-negative breast cancer that has specific genetic mutations.

Patient Parameters

Program Overview

The main goal of this study is to see how well the combination of Saruparib (AZD5305) and Camizestrant works compared to other treatments chosen by doctors for patients with advanced breast cancer that is HR-positive, HER2-negative, and has mutations in BRCA1, BRCA2, or PALB2 genes.

Description

Around 2,620 people will be screened to find about 500 participants for the study. Participants will be randomly assigned to one of three groups:

  • Group 1: Saruparib (AZD5305) plus Camizestrant
  • Group 2: Doctor's choice of CDK4/6 inhibitor plus endocrine therapy
  • Group 3: Doctor's choice of CDK4/6 inhibitor plus Camizestrant

Treatment will continue until the cancer progresses, side effects become too severe, or the participant decides to stop.

Eligibility Criteria

Inclusion Criteria

  • Adults, both women (pre/peri-menopausal and post-menopausal) and men
  • Diagnosed with HR-positive, HER2-negative breast cancer
  • Have advanced breast cancer that cannot be cured by surgery or has spread to other parts of the body
  • In good general health with a performance status of 0 or 1
  • Provide a tumor tissue sample
  • Have a genetic mutation in BRCA1, BRCA2, or PALB2
  • Have good organ and bone marrow function

Exclusion Criteria

  • History of certain blood disorders like MDS/AML
  • Tendency to bleed easily
  • Severe or ongoing low blood cell counts
  • Severe or uncontrolled diseases or infections
  • Severe nausea, vomiting, or digestive issues
  • History of another type of cancer
  • Ongoing severe side effects from previous cancer treatments
  • Cancer spread to the brain or spinal cord
  • Active hepatitis B, C, or HIV infections
  • Active tuberculosis
  • Heart problems or irregular heartbeats
  • Using hormone therapy for non-cancer conditions
  • Recent major surgery or injury
  • Recent radiation therapy
  • Previous treatment for advanced cancer, except for certain hormone therapies
  • Recent use of blood or growth factor support
  • Using certain medications or supplements that affect the liver or heart
  • Recent progression of breast cancer after specific treatments

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