Clinical Trial: NCT03164993
Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Oslo University Hospital |
| Information Provided By: | Oslo University Hospital |
| Last Update Posted: | 2024-10-15 |
Study Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled phase II study evaluating the safety and efficacy of Atezolizumab when combined with immunogenic chemotherapy in subjects with metastatic triple-negative breast cancer. Atezolizumab, pegylated liposomal doxorubicin and cyclophosphamide are the Investigational Medicinal Products (IMPs).
Official Title
ALICE: A Randomized Placebo-controlled Phase II Study Evaluating Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer
Conditions
Cancer, Breast, Triple Negative Breast Cancer
Intervention / Treatment
- Drug: Atezolizumab
- Drug: Pegylated liposomal doxorubicin
- Drug: Cyclophosphamide
- Other: Placebo
Other Study ID Numbers
- ML39079_ALICE
Start Date (Actual)
2017-06-01
Primary Completion Date (Actual)
2023-04-25
Study Completion Date (Actual)
2023-09-30
Enrollment (Actual)
68
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Oslo University Hospital |
| Information Provided By: | Oslo University Hospital |
| Last Update Posted: | 2024-10-15 |
Study Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled phase II study evaluating the safety and efficacy of Atezolizumab when combined with immunogenic chemotherapy in subjects with metastatic triple-negative breast cancer. Atezolizumab, pegylated liposomal doxorubicin and cyclophosphamide are the Investigational Medicinal Products (IMPs).
Official Title
ALICE: A Randomized Placebo-controlled Phase II Study Evaluating Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer
Conditions
Cancer, Breast, Triple Negative Breast Cancer
Intervention / Treatment
- Drug: Atezolizumab
- Drug: Pegylated liposomal doxorubicin
- Drug: Cyclophosphamide
- Other: Placebo
Other Study ID Numbers
- ML39079_ALICE
Start Date (Actual)
2017-06-01
Primary Completion Date (Actual)
2023-04-25
Study Completion Date (Actual)
2023-09-30
Enrollment (Actual)
68
Study Type
Interventional
Phase
Phase 2