This research study involves testing the safety and efficacy of an investigational
intervention for patients with triple-negative breast cancer (TNBC) that has spread, or
metastasized, to other parts the body and is PD-L1-negative.
The names of the study interventions involved in this study are:
Sacituzumab govitecan (Trodelvy™;IMMU-132)
Pembrolizumab (Keytruda®; MK-3475)
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
and effectiveness of an investigational drug or a combination of investigational drugs to
learn whether the drug or drug combination works in treating a specific disease.
"Investigational" means that the drug or drug combination is being studied.
The U.S. Food and Drug Administration (FDA) has approved Sacituzumab Govitecan for metastatic
triple-negative breast cancer, but it is currently approved only for patients who have had 2
or more prior regimens for metastatic disease. The U.S. Food and Drug Administration (FDA)
has approved Pembrolizumab for metastatic triple-negative breast cancer, but it is currently
approved only for patients with PD-L1-positive metastatic triple-negative breast cancer.
In this research study, we are:
Studying Sacituzumab Govitecan alone or in combination with Pembrolizumab as a possible
treatment for patients with metastatic triple-negative breast cancers that are
Sacituzumab Govitecan is composed of a chemotherapy drug, called Irinotecan, which is
attached to an antibody. Antibodies are proteins normally made by the immune system that
bind to substances that don't belong in the body to prevent harm. The antibody in this
study binds to certain types of cancer tumors, including triple-negative breast tumors.
Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is
an antibody (a type of human protein) designed to allow the body's own immune system to
seek out and destroy tumors. It has been used in previous research studies to treat
breast cancer, where it has been shown to be effective.
The overall goal of this study is to evaluate the effectiveness of either Sacituzumab
Govitecan alone or in combination with Pembrolizumab, in delaying the worsening of
triple-negative breast cancers that are PD-L1-negative.
The research study procedures include: screening for eligibility, research blood collections,
at least two research biopsies, paired research stool collections, questionnaires, data
collection, and study treatment including evaluations and follow up visits.
Participants will be randomized into one of two groups.
Group A: Sacituzumab Govitecan on days 1 and 8 and Pembrolizumab on day 1 of a 21-day
Group B: Sacituzumab Govitecan alone on days 1 and 8 of a 21-day cycle
Participants will receive study treatment for as long as they are benefitting from this
therapy. Participants will be followed for the rest of their life.
It is expected that about 110 people will take part in this research study.
Breast Cancer, Triple Negative Breast Cancer, PD-L1 Negative
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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