Study on Sacituzumab Govitecan with or without Pembrolizumab for Treating Metastatic Triple-Negative Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04468061

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment for patients with triple-negative breast cancer that has spread to other parts of the body and is PD-L1-negative. The study involves two drugs: Sacituzumab Govitecan and Pembrolizumab.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if Sacituzumab Govitecan, alone or combined with Pembrolizumab, can help delay the progression of triple-negative breast cancer that is PD-L1-negative. Sacituzumab Govitecan is a chemotherapy drug linked to an antibody that targets cancer cells, while Pembrolizumab is an immunotherapy that helps the immune system attack cancer. The study will involve screening for eligibility, collecting blood and tissue samples, and receiving the study treatment. Participants will be randomly assigned to receive either Sacituzumab Govitecan alone or with Pembrolizumab, and will continue treatment as long as it is beneficial.

Description

This Phase II clinical trial is exploring the safety and effectiveness of Sacituzumab Govitecan, with or without Pembrolizumab, for treating metastatic triple-negative breast cancer that is PD-L1-negative. Sacituzumab Govitecan is a chemotherapy drug attached to an antibody that targets cancer cells, while Pembrolizumab is an immunotherapy that helps the immune system fight cancer. The study aims to see if these treatments can delay the worsening of the cancer.

Participants will be randomly placed into one of two groups:

  • Group A: Receive Sacituzumab Govitecan on days 1 and 8, and Pembrolizumab on day 1 of a 21-day cycle.
  • Group B: Receive Sacituzumab Govitecan alone on days 1 and 8 of a 21-day cycle.

The study involves several procedures, including eligibility screening, blood and tissue sample collection, and follow-up visits. Participants will continue receiving the study treatment as long as it is beneficial. Approximately 110 people are expected to participate in this study.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed invasive breast cancer that is locally advanced or has spread to other parts of the body.
  • Cancer must be triple-negative, meaning low levels of estrogen and progesterone receptors and HER2-negative.
  • Cancer must be PD-L1-negative, with less than 1% expression of PD-L1 on immune cells.
  • Must not have received prior treatment for metastatic breast cancer.
  • Must have measurable disease according to specific criteria.
  • Agree to provide a tumor sample for research purposes.
  • Must not have received prior chemotherapy or biologic therapy for metastatic breast cancer.
  • Must be 18 years or older.
  • Must have good overall health with normal organ and marrow function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception during and after the study.
  • Must be able to understand and agree to the study requirements.

Exclusion Criteria

  • Have received any prior systemic anti-cancer therapy within 4 weeks of starting the study.
  • Have received prior treatment with anti-PD-1, PD-L1, or PD-L2 agents, or Sacituzumab Govitecan.
  • Have a known history of certain genetic conditions that increase risk for side effects.
  • Have untreated or symptomatic brain metastases.
  • Have had major surgery within 2 weeks before starting the study.
  • Have uncontrolled illnesses or infections.
  • Require chronic steroid or immunosuppressive therapy.
  • Have a history of autoimmune disease requiring treatment.
  • Have a history of lung inflammation requiring steroids.
  • Have a history of another cancer unless disease-free for at least 3 years.
  • Have a known history of HIV, Hepatitis B, or active Hepatitis C.
  • Have received a live vaccine within 28 days before starting the study.
  • Are breastfeeding.

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