Monitoring Tumor DNA in Blood During Capecitabine Treatment for Early Triple-negative Breast Cancer

Sponsor: Stanford University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04768426

Provider View

This study is exploring the use of a blood test to monitor tumor DNA in patients with early-stage triple-negative breast cancer receiving capecitabine treatment. The goal is to see if this test can help identify which patients benefit from the treatment and guide future therapies.

Patient Parameters

Program Overview

The study aims to use a blood test, known as a liquid biopsy, to track changes in tumor DNA in patients with early-stage triple-negative breast cancer who are being treated with capecitabine. By analyzing the tumor DNA in the blood, researchers hope to determine which patients are benefiting from the treatment. This information could help design future studies where patients might receive different treatments to lower their risk of cancer returning.

Description

The main goal of this study is to understand the tumor DNA profile in the blood of patients with triple-negative breast cancer who have some remaining cancer after initial chemotherapy and are now receiving capecitabine. Researchers will look at how the levels of tumor DNA in the blood relate to the genetic features of the cancer and the patients' survival. This could help in predicting which patients will benefit from capecitabine and guide future treatment options.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage I to III triple-negative breast cancer.
  • Low levels of estrogen and progesterone receptors (less than 10%).
  • Have some remaining cancer after at least 4 cycles of initial chemotherapy. Patients who had other investigational treatments during initial therapy can join.
  • Aged 18 years or older.
  • In good general health, with a performance status score of 0 to 2.
  • Any significant side effects from previous cancer treatments should be mild or resolved, except for hair loss and moderate nerve damage.
  • No signs of cancer spread to other parts of the body.
  • At least 4 weeks since the last chemotherapy treatment.
  • Healthy blood cell counts and liver and kidney function.
  • Planning to take capecitabine for 6 months or 8 cycles.
  • Women who can become pregnant must have a negative pregnancy test and agree to use birth control during the study and for 3 months after.
  • Men and their female partners must agree to use birth control during the study and for 3 months after.
  • Able to understand and sign a consent form agreeing to the study's requirements.

Exclusion Criteria

  • Have metastatic breast cancer (cancer that has spread).
  • Have not had surgery to remove the cancer.
  • Are pregnant or breastfeeding.
  • Have not completed planned radiation therapy after surgery.
  • Have HIV or active hepatitis B or C infections.
  • Have taken investigational drugs within 4 weeks before starting the study.
  • Cannot swallow pills.

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