Clinical Trial: NCT02947685
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Alliance Foundation Trials, LLC. |
| Information Provided By: | Alliance Foundation Trials, LLC. |
| Last Update Posted: | 2026-02-12 |
Study Overview
Brief Summary
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
Official Title
A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer
Conditions
HER-2 Positive Breast Cancer, Estrogen Receptor Positive Breast Cancer
Intervention / Treatment
- Drug: palbociclib
- Drug: trastuzumab
- Drug: pertuzumab
- Drug: letrozole
- Drug: Anastrozole
- Drug: Exemestane
- Drug: Fulvestrant
Other Study ID Numbers
- AFT-38
Start Date (Actual)
2017-06-21
Primary Completion Date (Actual)
2024-10-15
Study Completion Date (Estimated)
2026-07-31
Enrollment (Actual)
518
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Alliance Foundation Trials, LLC. |
| Information Provided By: | Alliance Foundation Trials, LLC. |
| Last Update Posted: | 2026-02-12 |
Study Overview
Brief Summary
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
Official Title
A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer
Conditions
HER-2 Positive Breast Cancer, Estrogen Receptor Positive Breast Cancer
Intervention / Treatment
- Drug: palbociclib
- Drug: trastuzumab
- Drug: pertuzumab
- Drug: letrozole
- Drug: Anastrozole
- Drug: Exemestane
- Drug: Fulvestrant
Other Study ID Numbers
- AFT-38
Start Date (Actual)
2017-06-21
Primary Completion Date (Actual)
2024-10-15
Study Completion Date (Estimated)
2026-07-31
Enrollment (Actual)
518
Study Type
Interventional
Phase
Phase 3