A study to assess the effects of pembrolizumab drug VS placebo in combination with chemotherapy in breast cancer patients
224 study locations across the U.S.
Trial Summary
In this trial, researchers will study the effects of pembrolizumab to slow or stop cancer spread on patients with triple-negative breast cancer. Pembrolizumab is an immunotherapy drug delivered through IV that helps the immune system to attack cancer cells and stop cancer spread. Triple-negative breast cancer means that the cancer cells don’t have estrogen or progesterone receptors (ER or PR) and also don’t make any or too much of the protein called HER2. (The cells test "negative" on all 3 tests.). Participants will be randomly divided into two groups. One group will not receive treatment, while the other group will receive Pembrolizumab as treatment.
Trial Design
1240 participants will be divided into 2 groups: the experiment group that tests out the drug pembrolizumab in combination with chemotherapy, and the control group receiving the placebo drug and chemotherapy. Patients will first receive 8 cycles of study treatment and then undergo surgery for the breast cancer. After surgery, patients will receive 9 cycles of study treatement for up to 10 years of endocrine therapy. Each cycle is 21 days long.
Inclusion Criteria
1. Are 18 years or older
2. Have a certain type of invasive breast cancer
3. Haver adequate organ function
Exclusion Criteria
1. Have HIV history
2. Have received prior treatment for breast cancer
3, Are pregnant or breastfeeding
Exclusion criteria are conditions or characteristics if they apply to you, may likely make you ineligible to participate in the study.
Inclusion criteria is a checklist of items, if they apply to you, may make you eligible to be included for the study.