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A Phase II Trial of Palbociclib in Combination With Trastuzumab and Endocrine Therapy in Patients With Previously-treated Locally Advanced or Metastatic HER2-positive Breast Cancer (PATRICIA II)
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.
Details
| Lead sponsor | SOLTI Breast Cancer Research Group |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 73 |
| Start date | 2015-07 |
| Completion | 2023-11-30 |
Conditions
- Metastatic Breast Cancer
Interventions
- Palbociclib
- Trastuzumab
- Endocrine therapy
- Chemotherapy
- Antibody-Drug Conjugates
Primary outcomes
- Progression-Free Survival at 6 months — From randomization date to date of first documentation of progression or death , whichever came first, assessed up to 6 months.
For cohorts A,B1 and B2: This was defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria), 6 months after randomization. - Progression-Free Survival (PFS)as Assessed by the Investigator [ Time Frame: From randomization date to date of first documentation of progression or death — From randomization date to date of first documentation of progression or death , whichever came first, assessed up to 4 years
For cohorts C: This will be defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria)
Countries
Spain