Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 1000
Summary
- Conditions
- Stage IIIA Breast Cancer AJCC v7
- Invasive Breast Carcinoma
- Stage 0 Breast Cancer AJCC v6 and v7
- Stage I Breast Cancer AJCC v7
- Stage IA Breast Cancer AJCC v7
- Stage IB Breast Cancer AJCC v7
- Stage II Breast Cancer AJCC v6 and v7
- Stage IIA Breast Cancer AJCC v6 and v7
- Stage IIB Breast Cancer AJCC v6 and v7
- Stage III Breast Cancer AJCC v7
- Stage IIIC Breast Cancer AJCC v7
- Triple-Negative Breast Carcinoma
- Stage IIIB Breast Cancer AJCC v7
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: 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 neo...
PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: 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. ADDITIONAL OBJECTIVE: 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 treatment. After completion of study treatment, patients are followed up every 6 months for 5 years, then annually thereafter until 10 years from treatment randomization.
Tracking Information
- NCT #
- NCT02954874
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lajos Pusztai Southwest Oncology Group