drugset / Trial / NCT03609047
Adjuvant Palbociclib in Elderly Patients With Breast Cancer
Phase 2
Active not recruiting
366 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Breast International Group · collabETOP IBCSG Partners Foundation · collabGerman Adjuvant Breast Cancer Group · collabGruppo Oncologico Italiano di Ricerca Clinica · collabPfizer · collabSOLTI Breast Cancer Research Group · collabSwedish Association of Breast Oncologists · collabUNICANCER · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.
Timeline
- Start
- 2019-06-14
- Primary completion
- 2026-09-30
- Completion
- 2026-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 90 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |