Study on Sacituzumab Govitecan for Treating Localized Triple Negative Breast Cancer (TNBC)

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04230109

Provider View

This clinical trial is exploring the use of sacituzumab govitecan, alone or in combination with pembrolizumab, to treat patients with localized triple negative breast cancer (TNBC).

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of sacituzumab govitecan, a drug being tested for treating localized triple negative breast cancer (TNBC). The study will also look at how well this drug works when combined with another drug called pembrolizumab. Sacituzumab govitecan is an antibody-drug conjugate, which means it combines an antibody with an anticancer drug to target and attack cancer cells.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of sacituzumab govitecan (SG) to see if it works for treating TNBC. The study involves two parts: one where patients receive SG alone, and another where SG is combined with pembrolizumab. The study will also explore future treatment options for other types of breast cancer.

Participants will be screened to see if they qualify and will receive SG for up to 12 weeks. After this, they may receive standard chemotherapy based on their doctor's advice. About 50 people are expected to participate in this study.

Sacituzumab govitecan is not yet approved by the FDA for treating metastatic TNBC. It works by using an antibody to target cancer cells and deliver the anticancer drug directly to them, helping to stop the cancer from growing or spreading.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, male or female.
  • Have a confirmed diagnosis of invasive breast cancer that has not been treated before.
  • Cancer must be triple negative, meaning it is negative for ER, PR, and HER2 markers.
  • Have at least one tumor that is 1 cm or larger, with no distant spread of cancer.
  • Be in good overall health with a performance status of 0 or 1.
  • Able to understand and sign a consent form and comply with study requirements.
  • Have adequate blood cell counts and organ function as determined by specific lab tests.

Exclusion Criteria

  • Have inflammatory or locally recurrent breast cancer.
  • Currently receiving treatment for another cancer or have been treated for another cancer in the past 3 years.
  • Have uncontrolled illnesses such as heart failure or psychiatric conditions that would interfere with the study.
  • Have significant heart disease or abnormal heart rhythms.
  • Have high or low blood pressure or a slow heart rate.
  • Pregnant or breastfeeding women cannot participate.
  • Known HIV-positive individuals on antiretroviral therapy are not eligible.
  • Individuals with a history of hepatitis B or C infection are excluded.

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