Adjuvant Palbociclib in Elderly Patients With Breast Cancer (Appalaches)
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|ClinicalTrials.gov Identifier: NCT03609047|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage II Breast Cancer Stage III||Drug: Palbociclib Drug: Docetaxel / cyclophosphamide Drug: doxorubicin/cyclophosphamide Drug: epirubicin/cyclophosphamide Drug: paclitaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized 2:1|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer|
|Actual Study Start Date :||June 14, 2019|
|Estimated Primary Completion Date :||June 13, 2024|
|Estimated Study Completion Date :||June 13, 2031|
Experimental: experimental palbociclib arm
Standard adjuvant endocrine therapy for a duration of at least 5 years + palbociclib (one capsule 125mg QD, orally, for 21 days followed by 7 days off treatment) for a total duration of up to 2 years.
Active Comparator: control chemotherapy arm
4 cycles docetaxel 75 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles doxorubicin 60 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles epirubicin 90 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles weekly paclitaxel 80 mg/m2 D1, D8, and D15 q3w
Followed by standard adjuvant endocrine therapy for a duration of at least 5 years.
Drug: Docetaxel / cyclophosphamide
- distant recurrence-free interval (D-RFI) rate [ Time Frame: 5 years after first patient inclusion ]
- Breast cancer specific survival [ Time Frame: 5 years after first patient inclusion ]
- Overall survival [ Time Frame: 5 years after first patient inclusion ]
- Incidence of permanent treatment discontinuation [ Time Frame: 5 years after first patient inclusion ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609047
|Contact: EORTC HQemail@example.com|
|Cliniques Universitaires Saint-Luc||Recruiting|
|Contact: Frank Cornelis|
|Institut Jules Bordet-Hopital Universitaire ULB||Recruiting|
|Contact: Lissandra Dal Lago|
|U.Z. Leuven - Campus Gasthuisberg||Recruiting|
|Contact: Hans Wildiers|
|Study Chair:||Hans Wildiers, MD, PhD||KU Leuven|