Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer
|ClinicalTrials.gov Identifier: NCT01849380|
Recruitment Status : Unknown
Verified May 2013 by Yu-Zhi Gang, Shandong University.
Recruitment status was: Not yet recruiting
First Posted : May 8, 2013
Last Update Posted : May 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Neoadjuvant Therapy||Drug: S-1 Drug: 5-FU||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||June 2018|
Experimental: Epirubicin-cyclophosphamide-S-1( ECS)
S-1(SuLi,QILU Pharmaceutical co.ltd ) was given at a standard dose of 40 mg/m2 twice daily in cycles of 14-day consecutive administration followed by a 14-day rest, combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly.
S-1(SuLi, QILU Pharmaceutical co.ltd ) was given at a standard dose of 40 mg/m2 twice daily in cycles of 14-day consecutive administration
Other Name: SuLi, QILU Pharmaceutical co.ltd
Active Comparator: Epirubicin-cyclophosphamide-5-FU (ECF)
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively), combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly.
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),
- Pathological complete response [ Time Frame: 12 weeks ]
Pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment No microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast and axilla.
Pathological response will be assessed considering all removed breast and lymphatic tissues from all surgeries.
The primary endpoint will be summarized as pathological complete remission rate for each treatment group.
Ultrasonic examination will be performed every 2 cycles of treatment for efficacy evaluation.
- Disease-free Survival [ Time Frame: 5 years ]
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Evaluation will be performed every 2 cycles of treatment during therapy, and follow-up will be performed every 3 months after therapy
- Tolerability and safety [ Time Frame: 12 weeks ]Reference to NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v 3.0. The endpoint will be summarized as events rate (%) for each treatment group
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849380
|Contact: Gang Z Yu, Dr; PhD||+86 email@example.com|
|the Second Hospital of Shandong Universtity||Not yet recruiting|
|Jinan, Shandong, China, 250033|
|Contact: Gang Z Yu, Dr; PhD +86 0531-85875048 firstname.lastname@example.org|
|Principal Investigator: Gang Z Yu, Dr; PhD|
|Principal Investigator:||Gang Z Yu, Dr; PhD||The Second Hospital of Shandong University|