Clinical Trial: NCT03726879
A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2024-11-05 |
Study Overview
Brief Summary
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Atezolizumab
- Drug: Placebo
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Paclitaxel
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Trastuzumab Emtansine
Other Study ID Numbers
- BO40747
Start Date (Actual)
2019-01-11
Primary Completion Date (Actual)
2021-02-05
Study Completion Date (Actual)
2023-08-24
Enrollment (Actual)
454
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2024-11-05 |
Study Overview
Brief Summary
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Atezolizumab
- Drug: Placebo
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Paclitaxel
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Trastuzumab Emtansine
Other Study ID Numbers
- BO40747
Start Date (Actual)
2019-01-11
Primary Completion Date (Actual)
2021-02-05
Study Completion Date (Actual)
2023-08-24
Enrollment (Actual)
454
Study Type
Interventional
Phase
Phase 3