Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer
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.
Timeline
- Start
- 2015-07
- Primary completion
- 2023-09-29
- Completion
- 2023-11-30
Publications
- Background Ciruelos E, Villagrasa P, Pascual T, Oliveira M, Pernas S, Pare L, Escriva-de-Romani S, Manso L, Adamo B, Martinez E, Cortes J, Vazquez S, Perello A, Garau I, Mele M, Martinez N, Montano A, Bermejo B, Morales S, Echarri MJ, Vega E, Gonzalez-Farre B, Martinez D, Galvan P, Canes J, Nuciforo P, Gonzalez X, Prat A. Palbociclib and Trastuzumab in HER2-Positive Advanced Breast Cancer: Results from the Phase II SOLTI-1303 PATRICIA Trial. Clin Cancer Res. 2020 Nov 15;26(22):5820-5829. doi: 10.1158/1078-0432.CCR-20-0844. Epub 2020 Sep 16.
- Peddi PF, Slamon DJ. Frontiers in HER2-positive breast cancer in 2020. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):48-52. doi: 10.1097/GCO.0000000000000677.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anastrozole | Other / unclassified | — | — |
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Eribulin | Small molecule | — | — |
| Subject | Exemestane | Small molecule | — | — |
| Subject | Fulvestrant | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
| Subject | Palbociclib | Small molecule | 200 mg | Oral |
| Subject | Tamoxifen | Small molecule | — | — |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Comparator | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |
| Comparator | Vinorelbine | Small molecule | — | — |