EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer
Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients
Sponsor: Hoffmann-La Roche
Listed as NCT00129935, this PHASE3 trial focuses on Breast Cancer and remains completed. Sponsored by Hoffmann-La Roche, it has been updated 10 times since 2004, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)Estimation of the 5-year disease-free survival in the control arm is 72%. The experimental arm is expected to increase the 5-year disease-free survival by 7% (up to 79%). With an alpha error of 0.05 and 80% power, 592 patients per arm are needed. Assuming a 17% post-randomization drop-out, 691 patients per arm are needed.
Estimation of the 5-year disease-free survival in the control arm is 72%. The experimental arm is expected to increase the 5-year disease-free survival by 7% (up to 79%). With an alpha error of 0.05 and 80% power, 592 patients per arm are needed. Assuming a 17% post-randomization drop-out, 691 patients per arm are needed.
Status Flow
Change History
10 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Apr 2023 — Jul 2024 [monthly]
Completed PHASE3
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Jan 2021 — Apr 2023 [monthly]
Completed PHASE3
▶ Show 5 earlier versions
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Nov 2019 — Jan 2021 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Jun 2018 — Nov 2019 [monthly]
Active Not Recruiting PHASE3
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Apr 2018 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
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Mar 2018 — Apr 2018 [monthly]
Active Not Recruiting PHASE3
Status: Completed → Active Not Recruiting
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Jan 2017 — Mar 2018 [monthly]
Completed PHASE3
First recorded
Feb 2004
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Hoffmann-La Roche
- Pfizer
- Sanofi
- Spanish Breast Cancer Research Group
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
A Coruña, Spain , Albacete, Spain , Alcorcón, Spain , Alicante, Spain , Badalona, Spain , Barbastro, Spain , Barcelona, Spain , Cadiz, Spain , Castellon, Spain , Córdoba, Spain and 29 more locations