Phase II Study of Repotrectinib With or Without Fulvestrant for Patients with Advanced Hormone Receptor-positive, HER2-negative Breast Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06408168

Provider View

This clinical trial is testing whether the combination of repotrectinib and fulvestrant can help control advanced breast cancer that is hormone receptor-positive and HER2-negative, in patients who have previously received endocrine therapy with a CDK4/6 inhibitor.

Patient Parameters

Program Overview

The purpose of this study is to determine if using repotrectinib, with or without fulvestrant, can effectively manage advanced invasive lobular carcinoma (a type of breast cancer) that is hormone receptor-positive and HER2-negative. The study focuses on patients who have already been treated with endocrine therapy and a CDK4/6 inhibitor.

Description

This study aims to evaluate how well the combination of repotrectinib and fulvestrant works in controlling advanced breast cancer over a period of 6 months. Researchers will also look at the effectiveness of the treatment over 12 months, the overall response rate, and the safety of the drugs. The study will explore how the treatment affects certain cancer markers and the tumor environment.

Participants will be divided into two groups based on their previous treatments. The study will monitor the progression of the cancer, the response to the treatment, and any side effects experienced by the participants. The goal is to find out if this combination therapy can provide a clinical benefit and improve survival rates for patients with this type of breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of invasive lobular carcinoma (ILC) with specific test results.
  • Cancer must be hormone receptor-positive and HER2-negative.
  • Must be willing to undergo a biopsy if the tumor is accessible.
  • Must have previously been treated with a CDK4/6 inhibitor.
  • Can have had prior chemotherapy or other specific cancer treatments.
  • Must not have had more than two chemotherapy treatments for metastatic cancer.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have measurable disease or specific bone lesions.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
  • Must have adequate organ and bone marrow function.
  • Must not have active hepatitis B or C infections unless controlled.
  • Must not have untreated or progressing brain metastases.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have severe symptoms from cancer that make endocrine therapy unsuitable.
  • Cannot have had recent cancer treatments within the last 4 weeks.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot be taking other experimental drugs.
  • Cannot have a history of lung inflammation or certain neurological symptoms.
  • Cannot have untreated or worsening brain metastases.
  • Cannot have allergies to similar drugs used in the study.
  • Cannot have mental health issues that affect study participation.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.

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