Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a Pdl-1 Inhibitor in Patients With Triple Negative Breast Cancer
The goal of this clinical research study is to learn if receiving atezolizumab and abraxane (nab-paclitaxel) in combination before surgery and atezolizumab alone after surgery can help to control breast cancer. The safety of this study drug combination will also be studied.
This is an investigational study. Atezolizumab is not FDA approved or commercially available. It is currently being used for research purposes only. Nab-paclitaxel is FDA approved and commercially available for the treatment of metastatic (has spread) breast cancer. The study doctor can explain how the study drug combination is designed to work.
Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a Pdl-1 Inhibitor in Patients With Triple Negative Breast Cancer|
- Pathologic Complete Response (pCR) of MPDL3280A in Combination with Nab-paclitaxel [ Time Frame: 6 months ]Pathologic complete response defined as no residual invasive disease in the breast or regional lymph nodes.
- Progression Free Survival (PFS) [ Time Frame: 6 months ]PFS estimated using the Kaplan-Meier method from the date of enrollment onto this study until the date of progression or death without evidence of progression.
|Actual Study Start Date:||February 4, 2016|
|Estimated Study Completion Date:||February 2021|
|Estimated Primary Completion Date:||February 2021 (Final data collection date for primary outcome measure)|
Experimental: MPDL3280A + Nab-paclitaxel
MPDL3280A administered at 1200 mg by vein every 3 weeks for 12 weeks in the neoadjuvant setting in combination with Nab-paclitaxel 100 mg/m2 by vein weekly for 12 weeks.
Within 4 weeks after surgery, participants start another 4 cycles of MPDL3280A in the adjuvant setting to complete a total of 8 cycles of treatment with MPDL3280A.
1200 mg by vein every 3 weeks for 12 weeks before surgery.
Within 4 weeks after surgery, participants start another 4 cycles of MPDL3280A.
Other Name: AtezolizumabDrug: Nab-paclitaxel
100 mg/m2 by vein weekly for 12 weeks before surgery.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02530489
|Contact: Jennifer Litton, MD||713-792-2817|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jennifer Litton, MD||M.D. Anderson Cancer Center|