Study on the Effectiveness and Safety of Different Treatment Combinations for Breast Cancer

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04802759

Provider View

This clinical trial is exploring various treatment combinations for breast cancer to determine their effectiveness and safety. The study includes participants with different types of breast cancer that have progressed despite previous treatments.

Patient Parameters

Program Overview

This study is testing different combinations of treatments for breast cancer to see how well they work and how safe they are. It includes two groups of participants: one with breast cancer that is estrogen receptor-positive and HER2-negative, and another with breast cancer that is estrogen receptor-positive and HER2-positive. The study is flexible, allowing new treatments to be added or existing ones to be adjusted based on their effectiveness and safety. Participants will be randomly assigned to different treatment groups, and if their cancer progresses or they experience severe side effects, they may be offered a different treatment combination later in the study.

Eligibility Criteria

Inclusion Criteria

  • For Cohort 1:

    • Good overall health with a performance status of 0 or 1.
    • Estrogen receptor-positive breast cancer.
    • Cancer has progressed after previous hormone therapy, including a CDK4/6 inhibitor.
    • Postmenopausal women.
    • Life expectancy of at least 3 months.
    • Willing to provide a tumor sample for testing.
    • Measurable cancer according to specific criteria.
    • Stable blood and organ function.
    • Stable anticoagulant treatment if needed.

  • For Cohort 2:

    • Good overall health with a performance status of 0 or 1.
    • Estrogen receptor-positive and HER2-positive breast cancer.
    • Postmenopausal women.
    • Life expectancy of at least 3 months.
    • Willing to provide a tumor sample for testing.
    • Measurable cancer according to specific criteria.
    • Adequate heart function.
    • Stable blood and organ function.
    • Stable anticoagulant treatment if needed.

  • For Stage 2:

    • Able to start Stage 2 treatment within 3 months if cancer progresses or side effects occur, and if a treatment slot is available.
    • Provide a tumor sample if cancer progresses or side effects occur.

Exclusion Criteria

  • Previous treatment with any study drugs.
  • Recent participation in another clinical trial.
  • Recent treatment for breast cancer or with certain medications.
  • Unresolved side effects from previous cancer treatments.
  • Only eligible for the control group.
  • Previous organ transplants.
  • Recent major surgery or need for surgery during the study.
  • Other cancers within the last 2 years, except for certain low-risk cancers.
  • Uncontrolled fluid buildup or pain related to cancer.
  • Uncontrolled high calcium levels.
  • Untreated or worsening brain cancer.
  • History of certain lung diseases or infections.
  • Heart problems or active infections.
  • Positive tests for HIV, Hepatitis B, or Hepatitis C.
  • Digestive issues affecting medication absorption.
  • Allergies to study drugs.
  • Specific exclusions for certain treatment combinations, such as lung disease or diabetes.

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