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absolute neutrophil count
monoclonal antibody therapy
triple-negative breast cancer
ductal carcinoma in situ
axillary lymph node dissection
core needle biopsy
sentinel lymph node biopsy
This randomized phase III trial studies how well pembrolizumab works in treating patients
with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as
pembrolizumab, may help the body's immune system attack the cancer, and may interfere with
the ability of tumor cells to grow and spread.
I. To compare invasive disease-free survival (IDFS) of patients with triple-negative (TNBC)
or low estrogen receptor (ER)-positive and/or HER2 borderline breast cancer who have >= 1 cm
residual invasive breast cancer and/or positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3) after
neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 (pembrolizumab) adjuvant
therapy compared to no MK-3475 (pembrolizumab), in both the entire study population and also
in the PD-L1 positive subset.
I. To compare the effects of MK-3475 (pembrolizumab) on overall survival (OS) and distant
recurrence-free survival (DRFS) between the two randomized arms for the PD-L1 positive
patients and then all patients.
II. To assess the toxicity and tolerability of MK-3475 (pembrolizumab) in this patient
population with or without radiation therapy.
BEHAVIORAL AND HEALTH OUTCOMES (BAHO) STUDY OBJECTIVES:
I. To examine the association between biomarkers of inflammation and quality of life and
patient reported outcomes between the two groups during and at the end of therapy.
II. To examine the long-term and late effects of treatment on patient-reported outcomes.
I. To collect tissue and whole blood for processing and banking in anticipation of future
correlative studies in this patient population.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (OBSERVATION): Patients receive no treatment but are monitored at standard clinical
intervals during first year after randomization. Patients are examined every 12 weeks for 1
year, and every 6 months for 4 years, then annually for 5 years.
ARM II (PEMBROLIZUMAB): Patients receive pembrolizumab intravenously (IV) over 30 minutes on
days 1 and 22. Cycles repeat every 42 days for 52 weeks in the absence of disease progression
or unacceptable toxicity.
All patients may undergo radiation therapy within 12 weeks of last breast cancer operation or
After completion of study treatment, patients are followed up every 6 months for 5 years,
then annually thereafter until 10 years from treatment randomization.
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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