Phase II Study of Sacituzumab Govitecan and Pembrolizumab Before Surgery for Early-stage Triple-negative Breast Cancer Resistant to Immunochemotherapy

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05675579

Provider View

This clinical trial is exploring whether the combination of sacituzumab govitecan and pembrolizumab, given before surgery, can help control early-stage triple-negative breast cancer that hasn't responded well to other treatments.

Patient Parameters

Program Overview

The aim of this study is to find out if using sacituzumab govitecan and pembrolizumab together before surgery can effectively treat early-stage triple-negative breast cancer (TNBC) that has not responded to previous immunochemotherapy. Researchers are also looking at the safety of this treatment and how well it works in terms of reducing cancer and preventing it from coming back.

Description

The main goal of this study is to see if the combination of sacituzumab govitecan and pembrolizumab can lead to a complete response or minimal cancer presence in patients with early-stage triple-negative breast cancer that has resisted previous treatments.

Secondary goals include:

  • Checking the safety of this treatment combination.
  • Measuring how many patients respond to the treatment.
  • Evaluating how long patients remain free from cancer returning.
  • Assessing survival rates over three years.

Researchers will also explore specific markers in tumor tissues and blood that might predict how well patients respond to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older, both men and women.
  • Confirmed diagnosis of breast cancer through lab tests.
  • Early-stage disease with specific tumor and lymph node involvement.
  • Cancer that is negative for certain hormone receptors and HER2, according to guidelines.
  • Started initial treatment with a specific regimen including pembrolizumab, paclitaxel, and carboplatin.
  • Good overall health with a performance status score of 0 or 1.
  • No reduction or an increase in tumor size after initial treatment, as shown by scans.
  • Negative pregnancy test for women of childbearing potential before starting the study medication.
  • Willingness to undergo a biopsy after initial treatment.
  • Agreement to use effective birth control methods during the study and for at least four months after the last dose of the study drug.
  • Adequate organ function as shown by specific blood tests.

Exclusion Criteria

  • Stage IV breast cancer.
  • Previous cancer treatments for the current cancer event.
  • Pregnant or planning to become pregnant during the study.
  • Digestive tract diseases or history of colitis.
  • Active autoimmune diseases needing treatment or conditions requiring immunosuppression.
  • Recent heart attack, severe heart failure, or unstable heart conditions.
  • Known HIV or active hepatitis B or C infections.
  • Cognitive impairments.
  • Other major health issues affecting treatment.
  • Recent live vaccinations within 30 days before starting the study.

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