Clinical Trial: NCT02448420
Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | SOLTI Breast Cancer Research Group |
| Information Provided By: | SOLTI Breast Cancer Research Group |
| Last Update Posted: | 2024-04-18 |
Study Overview
Brief Summary
PATRICIA is a phase II, open-label, multicentre, Simon's two-stage-design study of the combination of palbociclib plus trastuzumab, with or without letrozole, in post-menopausal patients with HER2-positive locally advanced or metastatic breast cancer (MBC) who have received chemotherapy and treatment with trastuzumab for their metastatic disease. Cohorts A, B1, and B2 based on their HR status and treatment allocation were planned.
Cohort A included patients with hormone receptor-negative, HER2 positive breast cancer, who received trastuzumab + palbociclib.
Cohort B1 included patients with hormone receptor-positive, HER2 positive breast cancer, who received trastuzumab + palbociclib.
Cohort B2 included patients with hormone receptor-positive, HER2 positive breast cancer, who received trastuzumab + palbociclib + letrozole.
The aim of the PATRICIA study is to test the hypothesis that the addition of Palbociclib to standard therapy is well tolerated and can provide a benefit in progression-free survival.
Based on interim results from this trial that support the benefit of CDK4 / 6 inhibition in luminal disease, two additional cohorts will be included.
Official Title
Conditions
Intervention / Treatment
- Drug: Palbociclib
- Drug: Trastuzumab
- Drug: Endocrine therapy
- Drug: Chemotherapy
- Drug: Antibody-Drug Conjugates
Other Study ID Numbers
- SOLTI-1303
- 2014-005006-38
- 2014
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | SOLTI Breast Cancer Research Group |
| Information Provided By: | SOLTI Breast Cancer Research Group |
| Last Update Posted: | 2024-04-18 |
Study Overview
Brief Summary
PATRICIA is a phase II, open-label, multicentre, Simon's two-stage-design study of the combination of palbociclib plus trastuzumab, with or without letrozole, in post-menopausal patients with HER2-positive locally advanced or metastatic breast cancer (MBC) who have received chemotherapy and treatment with trastuzumab for their metastatic disease. Cohorts A, B1, and B2 based on their HR status and treatment allocation were planned.
Cohort A included patients with hormone receptor-negative, HER2 positive breast cancer, who received trastuzumab + palbociclib.
Cohort B1 included patients with hormone receptor-positive, HER2 positive breast cancer, who received trastuzumab + palbociclib.
Cohort B2 included patients with hormone receptor-positive, HER2 positive breast cancer, who received trastuzumab + palbociclib + letrozole.
The aim of the PATRICIA study is to test the hypothesis that the addition of Palbociclib to standard therapy is well tolerated and can provide a benefit in progression-free survival.
Based on interim results from this trial that support the benefit of CDK4 / 6 inhibition in luminal disease, two additional cohorts will be included.
Official Title
Conditions
Intervention / Treatment
- Drug: Palbociclib
- Drug: Trastuzumab
- Drug: Endocrine therapy
- Drug: Chemotherapy
- Drug: Antibody-Drug Conjugates
Other Study ID Numbers
- SOLTI-1303
- 2014-005006-38
- 2014