NCT03609047

Adjuvant Palbociclib in Elderly Patients With Breast Cancer

A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this trial is 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. This is a two-arm open-label multi-center randomized (2:1) non-comparative phase II study in elderly patients with stage II/III, ER+, HER2- early breast cancer for whom treatment with chemotherapy is indicated. Patients will be randomized with a 2:1 allocation rate to the following treatment arm: * experimental palbociclib arm: Standard adjuvant endocrine therapy for a duration of at least 5 years + palbociclib for a total duration of up to 2 years. * control chemotherapy arm: adjuvant chemotherapy (4 cycles of docetaxel/doxorubicin/epirubicin-cyclophosphamide; or of weekly paclitaxel D1, D8, and D15 q3w if a 3 weekly schedule is not desired), followed by standard adjuvant endocrine therapy for a duration of at least 5 years. The primary endpoint of the study is the 3-year D-RFI rate in the experimental arm.

Conditions

• Breast Cancer Stage II
• Breast Cancer Stage III

Interventions

Type	Name	Description
DRUG	Palbociclib	CDK4/6 inhibitor
DRUG	Docetaxel / cyclophosphamide	Adjuvant Chemotherapy
DRUG	doxorubicin/cyclophosphamide	Adjuvant Chemotherapy
DRUG	epirubicin/cyclophosphamide	Adjuvant Chemotherapy
DRUG	paclitaxel	Adjuvant Chemotherapy

Timeline

• Start date: 2019-06-14
• Primary completion: 2026-06-30
• Completion: 2032-09-30
• First posted: 2018-08-01
• Last updated: 2024-01-24

Locations

73 sites across 9 countries: Belgium, France, Germany, Italy, Jordan, Poland, Portugal, Spain, United Kingdom