Study on Using Circulating Tumor DNA to Guide Chemotherapy Changes in Advanced Triple-Negative Breast Cancer

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05770531

Provider View

This clinical trial is exploring whether monitoring small pieces of tumor DNA in the blood can help doctors decide when to change chemotherapy treatments for patients with advanced triple-negative breast cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to find out if checking for circulating tumor DNA (ctDNA) in the blood can help doctors identify when the current chemotherapy is not working for patients with metastatic triple-negative breast cancer (TNBC). By detecting ctDNA, doctors might be able to switch to a different treatment sooner, potentially improving patient outcomes. The alternative treatment being considered is sacituzumab govitecan, a targeted therapy that delivers chemotherapy directly to cancer cells.

Description

The main goal of this study is to see if using ctDNA to guide changes in treatment can help patients with metastatic TNBC live longer without their cancer getting worse, compared to using standard imaging tests alone.

Secondary goals include evaluating how well the cancer responds to treatment changes guided by ctDNA and comparing overall survival rates between patients using ctDNA guidance and those using standard imaging. The study will also explore if ctDNA can provide unique insights into the cancer's behavior.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will receive standard chemotherapy and have blood samples collected for research purposes.
  • Group B: Patients will receive standard chemotherapy and have blood samples collected to check ctDNA levels. Based on ctDNA results, they may switch to sacituzumab govitecan if needed.

Both groups will undergo regular CT or MRI scans to monitor the cancer. After completing the study treatment, patients will have follow-up visits at 3, 6, 9, and 12 months, and then every 6 months for up to 3 years.

Eligibility Criteria

Inclusion Criteria

  • Have advanced (stage IV) triple-negative breast cancer that has spread to other parts of the body.
  • Be 18 years or older, male or female.
  • Have not received chemotherapy for metastatic disease before.
  • Have measurable cancer according to standard criteria.
  • Have a good overall health status, with an ECOG performance score of 0 to 2.
  • Be able to understand and sign a consent form.
  • Have adequate blood cell counts and organ function based on specific lab tests.
  • Agree to use effective birth control during the study and for 30 days after the last treatment dose if not postmenopausal or surgically sterile.

Exclusion Criteria

  • Have cancer that has spread to the brain or spinal cord lining.
  • Have uncontrolled pain from the cancer.
  • Have high calcium levels in the blood that are not controlled.
  • Have had another type of cancer within the last 5 years, except for certain skin cancers or cervical cancer.
  • Be pregnant or breastfeeding.
  • Have significant uncontrolled health issues that could interfere with the study.
  • Have serious heart conditions or have had a heart attack in the last 3 months.
  • Have had major surgery within 4 weeks before starting the study.
  • Have psychiatric or social issues that could affect safety or compliance with the study.

Locations

FACILITYZIPCITYSTATE
Vanderbilt University/Ingram Cancer Center37232NashvilleTennessee

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