Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a Pdl-1 Inhibitor in Patients With Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02530489|
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : September 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: MPDL3280A Drug: Nab-paclitaxel||Phase 2|
Study Drug Administration:
Each study cycle is 21 days. You will receive the study drugs in 2 sets of 4 cycles (4 cycles before surgery and 4 cycles after surgery).
On Day 1 of Cycle 1, you will receive atezolizumab by vein over about 60 minutes.
On Day 1 of each later cycle before and after surgery, if you tolerated the first infusion, you will receive future infusions of atezolizumab by vein over 30 minutes.
You will receive nab-paclitaxel by vein over about 30 minutes on Days 1, 8, and 15 of Cycles 1-4 before surgery.
If you have side effects, the study doctor may decide to lower your dose of study drugs or have you stop taking the drugs. You may be able to restart the study drug later at the same or a lower dose. The study doctor will discuss this with you.
On Day 1 of all cycles:
- You will have a physical exam.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- During Cycle 3, you will have an ultrasound of your breast(s) before surgery. Additional imaging may be done as part of your routine care, if the doctor thinks it is needed.
- During Cycle 3, blood (about 1 tablespoon each time) will be drawn before surgery and at the time of surgery.
On Days 8 & 15 of Cycles 1-4, blood (about 2 tablespoons) will be drawn for routine testing.
Within 6 weeks after you have received 4 cycles of study drugs, you will have surgery as part of your standard of care and part of the tumor tissue that is removed during surgery will be collected for biomarker testing. You will be given a surgery consent form that describes the procedure and its risks.
On Day 21 of Cycle 8, blood (about 1 tablespoon) will be drawn for routine and biomarker testing.
Length of Treatment:
You may receive the study drugs for about 4 cycles before your surgery and about 4 cycles after your surgery (8 cycles total). You will no longer be able to take the study drug, if intolerable side effects occur, or if you are unable to follow study directions. You may be able to continue taking the study drugs if the disease gets worse if the doctor thinks it is in your best interest.
Your participation on the study will be over after follow-up.
Every 6 months for up to 3 years, you will either have a clinic visit or you will be called by a member of the study staff and asked how you are doing. If you are called, each call should last about 15-20 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 4, 2016|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2022|
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: Atezolizumab
100 mg/m2 by vein weekly for 12 weeks before surgery.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|