Protocol Summary

Protocol No.

107224 (S1418)

Principal Investigator

Buys, Saundra

Phase

III

Age Group

Adult

ClinicalTrials.Gov

NCT02954874 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Title

Randomized Phase III Trial to Evaluate the Efficacy and Safety of Pembrolizumab as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvant Chemotherapy

Objective

1.1 Primary Objective
a. To compare invasive disease-free survival (IDFS) of patients with triple-negative breast cancer (TNBC) who have either 1 cm residual invasive breast cancer and/or positive lymph nodes (ypN+) 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.

1.2 Secondary Objectives
a. 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.
b. To assess the toxicity and tolerability of MK-3475 (pembrolizumab) in this patient population with or without radiation therapy.

1.3 BAHO Study Objectives
a. 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.
b. To examine the long-term and late effects of treatment on patient-reported outcomes.

1.4 Additional Objectives
a. To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population.

Applicable Disease Sites

Breast

Participating Institutions

HCI Farmington; HCI South Jordan; Huntsman Cancer Institute

Status

Open


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