This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for hormone receptor positive breast cancer. The interventions involved in this study are: * Pembrolizumab (MK-3475; Keytruda™) * Nab-Paclitaxel (Abraxane
This research study is a Pilot Study, which is the first time investigators are examining this study intervention. In this research study, the investigators are looking at how the participants body and tumor respond to the combination of Nab-paclitaxel and Pembrolizumab. Also, the investigators will be examining the participants tumor tissue to learn more about the disease. The FDA (the U.S. Food and Drug Administration) has not approved Pembrolizumab for this specific disease; but it has been approved in the United States for the treatment of other diseases. The FDA has not approved Nab-paclitaxel as a treatment option for this type of breast cancer; but it has been approved in the United States for the treatment of metastatic breast cancer (breast cancer that has spread to other parts of the body). Pembrolizumab is a medicine that may treat cancer by working with the participant's immune system. The immune system is the body's natural defense against disease. The immune system sends types of cells called "T cells" throughout the body to detect and fight infections and diseases, including cancer. For some types of cancer, the T cells do not work as they should and are prevented from attacking the tumors. Pembrolizumab is thought to work by blocking a protein in the T cells called PD-1 ("programmed death 1"), which then allows these cells and other parts of the immune system to attack tumors. Nab-paclitaxel (Abraxane) is part of a class of medications called antimicrotubule agents. It works by stopping the growth and spread of cancer cells by blocking the action of proteins called microtubules. The combination of Pembrolizumab and Nab-paclitaxel is investigational. "Investigational" means that the combination of study drugs is being studied. The study drugs, when given separately, work in different ways to stop the cancer cells from growing and spreading. However, it is not known if giving the two study drugs at the same time will have a better anti-cancer effect than giving each treatment on its own.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Pembrolizumab will be administered in clinic every three weeks.
Nab-Paclitaxel will be administered in clinic every week.
Biopsies for research purposes will be performed at three separate timepoints during treatment.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Change in the Biomarker (PD-L1) Expression
PDL1 H-Score by Immunohistochemistry (≥ 100 versus 0-99) change from baseline biopsy to biopsy after 2-week monotherapy (from C1D1 to C3D1). The minimum score is 0 and the higher the score the worse.
Time frame: 2 weeks
Change in Percentage of Stromal Tumor Infiltrating Lymphocytes After Monotherapy Treatment
stromal tumor infiltrating lymphocytes (sTIL) is measured at C1D1 and C3D1 of the treatment.
Time frame: from C1D1 to C3D1 (2 weeks)
Pathologic Complete Response Rate
Response is measured by RCB score.RCB 0 (equal to pCR), RCB I(minimal burden), RCB II (moderate burden) and RCB III(extensive burden)
Time frame: 2 years
Overall Response Rate
Overall response rate, assessed radiographically by both Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) following treatment with combination nab-paclitaxel and pembrolizumab in the neoadjuvant setting. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the baseline LD. Overall response = CR+PR+SD
Time frame: 2 years
Disease-Free Survival
Disease-free survival (DFS) will be defined from the time of randomization until the occurrence of the first of the following events: * Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast. * Contralateral invasive breast cancer, * Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description. * Death from any cause
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Time frame: 3 years from randomization