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Appalaches: Palbociclib as an Alternative to Chemotherapy in Elderly Patients With Early Breast Cancer
NCT03609047Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2019
- Primary completion
- Sep 2026
- Countries
- 9
- Sponsor
- European Organisation for Research and Treatment of Cancer
- Modality
- Small Molecules
- Drugs
- palbociclib
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, open-label trial of palbociclib in breast cancer (2 arms), sponsored by European Organisation for Research and Treatment of Cancer. Primary endpoint: Distant Recurrence-Free Interval at 5 years. Started Jun 2019; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
experimental palbociclib arm
Standard adjuvant endocrine therapy for at least 5 years + palbociclib for up to 2 years.
control chemotherapy arm
Adjuvant chemotherapy (4 cycles) followed by standard adjuvant endocrine therapy for at least 5 years.
03
Who it enrols
Elderly patients (>=70 years) with stage II/III ER+/HER2- early breast cancer who have undergone recent curative surgery and are candidates for adjuvant chemotherapy.
04
Endpoints
Primary
Distant Recurrence-Free Interval
Secondary
Breast Cancer Specific Survival
Overall Survival
Incidence of permanent treatment discontinuation
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