Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Doctor's Choice Treatment in Patients with Triple Negative Breast Cancer with Remaining Disease After Surgery and Pre-Surgery Therapy
Sponsor: Gilead Sciences
ClinicalTrials ID:NCT05633654
This clinical trial is testing whether the combination of sacituzumab govitecan-hziy and pembrolizumab is safe and effective compared to standard treatments chosen by doctors for patients with triple negative breast cancer that still has some cancer left after surgery and initial treatments.
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Program Overview
The purpose of this study is to determine if the experimental drug sacituzumab govitecan-hziy, when used with pembrolizumab after surgery, is a safe and effective treatment for patients with triple negative breast cancer that remains after surgery and pre-surgery therapy. This will be compared to the usual treatments chosen by doctors, which may include pembrolizumab alone or with another drug called capecitabine.
Eligibility Criteria
Inclusion Criteria
- Be over 18 years old and have triple negative breast cancer that still has some cancer left in the breast or lymph nodes after initial treatments and surgery.
- Triple negative breast cancer for this study means the cancer has low levels of estrogen and progesterone receptors and is HER2-negative.
- Have had all visible cancer removed through surgery and have recovered from the surgery.
- Provide tissue samples from before and after initial treatments.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have received and recovered from appropriate radiation therapy before starting the study treatment.
- Have good organ function as determined by medical tests.
Exclusion Criteria
- Have stage IV breast cancer or a history of any other invasive breast cancer.
- Have previously been treated with certain immune therapies or HER2-targeted treatments.
- Show signs of cancer returning after initial treatments and surgery.
- Have been treated with specific types of cancer drugs called topoisomerase inhibitors or antibody-drug conjugates.
- Have genetic mutations in the BRCA genes.
- Have had a heart attack or unstable chest pain within the last 6 months, or have serious heart rhythm problems or a heart pumping ability below 50%.
- Have active serious infections that need treatment with antibiotics or other medications.
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