Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02489448
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2015-07-01
Brief Title:
Neoadjuvant MEDI4736 Concomitant With Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III Triple Negative Breast Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Single Arm Neoadjuvant Phase III Study of MEDI4736 Anti-PD-L1 Antibody Concomitant With Weekly Nab-paclitaxel and Dose-dense DoxorubicinCyclophosphamide ddAC Chemotherapy for Clinical Stage I-III Triple Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to address the following hypotheses i Anti-PD-L1 therapy with MEDI4736 administered concomitantly with weekly nab-paclitaxel followed by MEDI4736 concomitant with ddAC neoadjuvant chemotherapy will induce higher pathologic complete response pCR rate 55 in triple negative breast cancer than historical pCR rates 30-40 observed with chemotherapy alone ii MEDI4736 can be safely co-administered at full dose with sequential with nab-paclitaxel 100mgm2 and ddAC 60 mgm2 and 600 mgm2 respectively
Detailed Description:
The primary objective of the Phase I portion of the trial is to assess the safety of MEDI4736 combined with chemotherapy and determine if full dose of MEDI4736 can be administered concomitantly with full dose weekly nab-paclitaxel followed by dose-dense AC chemotherapies respectively
The primary objective of the Phase II portion of the study is to estimate the pCR rate with MEDI4736 in combination with weekly nab-paclitaxel x 12 treatments followed by MEDI4736 in combination with ddAC x 4 treatments for estrogen receptor ER progesterone receptor PR and HER2 negative triple negative TNBC clinical stage I-III breast cancer Pathologic complete response is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy ie ypT0Tis ypN0
Secondary objectives include to assess the safety and toxicity of adding anti-PD-L1 antibody MEDI4736 to standard of care neoadjuvant chemotherapy in the Phase II portion of the trial The study will also monitor for events of special clinical interest with a suspected auto-immunologic etiology including grade 3 colitis hyperthyroidism hypophysitis hypothyroidism pneumonitis rash and anti-drug-antibody ADA immune complex disease manifested by symptoms of arthralgias abdominal pain back pain and vasculitis
Exploratory objectives include to assess correlation between response to therapy and immune parameters of the tumor at baseline and post-treatment in patients who have residual cancer after therapy
The primary objective of the Phase II portion of the study is to estimate the pCR rate with MEDI4736 in combination with weekly nab-paclitaxel x 12 treatments followed by MEDI4736 in combination with ddAC x 4 treatments for estrogen receptor ER progesterone receptor PR and HER2 negative triple negative TNBC clinical stage I-III breast cancer Pathologic complete response is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy ie ypT0Tis ypN0
Secondary objectives include to assess the safety and toxicity of adding anti-PD-L1 antibody MEDI4736 to standard of care neoadjuvant chemotherapy in the Phase II portion of the trial The study will also monitor for events of special clinical interest with a suspected auto-immunologic etiology including grade 3 colitis hyperthyroidism hypophysitis hypothyroidism pneumonitis rash and anti-drug-antibody ADA immune complex disease manifested by symptoms of arthralgias abdominal pain back pain and vasculitis
Exploratory objectives include to assess correlation between response to therapy and immune parameters of the tumor at baseline and post-treatment in patients who have residual cancer after therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None