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 28, 2021
|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, 2025|
|Estimated Study Completion Date :||June 13, 2032|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609047
|Contact: EORTC HQfirstname.lastname@example.org|
|Study Chair:||Hans Wildiers, MD, PhD||KU Leuven|