Study on Using Gene Signatures to Guide Treatment for Hormone Receptor-Positive Metastatic Breast Cancer

Sponsor: Sonya Reid

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05693766

Provider View

This clinical trial is exploring how a chemotherapy drug called capecitabine affects survival in patients with a specific type of hormone receptor-positive metastatic breast cancer. The study will compare this chemotherapy with hormone-based treatments to see which is more effective.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effects of a chemotherapy drug, capecitabine, on patients with a type of hormone receptor-positive metastatic breast cancer that is not classified as Luminal A. Researchers aim to determine if starting chemotherapy early can improve outcomes compared to hormone-based treatments. The study will also look at the safety and side effects of these treatments and explore if certain genetic changes in the cancer can predict how well the treatment works.

Description

This study has several goals:

  • The main goal is to see if starting chemotherapy early with a drug called capecitabine is more effective than hormone-based treatments in fighting tumors in patients with a specific type of hormone receptor-positive metastatic breast cancer.

  • The study will also compare the safety and side effects of capecitabine with hormone-based treatments.

  • Researchers will investigate if certain genetic changes in the cancer, detected through blood tests, can predict how well the treatment works or if new genetic changes appear when the cancer progresses, which might indicate resistance to the therapy.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Age 18 or older.
  • Good overall health with a performance status score of 0 or 1.
  • Have stage IV invasive breast cancer or cancer that has returned and cannot be removed by surgery, with specific hormone receptor and HER2 status.
  • Previously treated with certain hormone therapies and a CDK4/6 inhibitor.
  • Prior radiation therapy is allowed if completed at least 2 weeks before joining the study and any side effects have reduced to mild levels.
  • Patients with stable brain metastases from breast cancer are eligible if they have been stable for more than 4 weeks after radiation and are not on steroids.
  • Must have cancer that can be evaluated through scans or tests.
  • Must have adequate organ function as shown by specific blood test results.
  • For patients in the randomized part of the study, tumors must be classified as non-Luminal A using specific tests.

Exclusion Criteria

  • Have received chemotherapy for metastatic breast cancer before.
  • Have had another type of cancer within the last 2 years, except for certain low-risk cancers that have been treated successfully.
  • Have ongoing symptoms from previous treatments that are not mild, except for certain conditions like menopausal symptoms, hair loss, or mild nerve issues.
  • Are pregnant or breastfeeding.

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