Nab-Paclitaxel and Atezolizumab Before Surgery in Treating Patients With Triple Negative Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Adenocarcinoma
- Invasive Breast Carcinoma
- Triple-Negative Breast Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group 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 evaluate the rate of pathologic complete response (pCR)/residual cancer burden (RCB)-0 + residual cancer burden (RCB)-I responses in patients with triple negative breast cancer (TNBC), who were non-responders to initial anthracycline and cyclophosphamide chemotherapy, treate...
PRIMARY OBJECTIVE: I. To evaluate the rate of pathologic complete response (pCR)/residual cancer burden (RCB)-0 + residual cancer burden (RCB)-I responses in patients with triple negative breast cancer (TNBC), who were non-responders to initial anthracycline and cyclophosphamide chemotherapy, treated with atezolizumab in combination with nab-paclitaxel in the neoadjuvant setting. SECONDARY OBJECTIVES: I. To estimate progression free survival (PFS) distribution of triple negative breast cancer (TNBC) patients who were non-responders to initial anthracycline and cyclophosphamide chemotherapy, treated with atezolizumab in combination with nab-paclitaxel in the neoadjuvant setting. II. To determine the safety of atezolizumab in combination with nab-paclitaxel in the neoadjuvant setting. EXPLORATORY OBJECTIVE: I. To investigate the association between biomarkers in the peripheral blood and tumor tissue with efficacy for TNBC patients treated with atezolizumab in combination with nab-paclitaxel in the neoadjuvant setting. OUTLINE: NEOADJUVANT: Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1 and nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo definitive breast surgery within 6 weeks of the completion of treatment. ADJUVANT: Within 4 weeks after surgery, patients receive atezolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.
Tracking Information
- NCT #
- NCT02530489
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Clinton Yam M.D. Anderson Cancer Center
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