Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer
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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
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Condition or disease | Intervention/treatment | Phase |
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Breast Neoplasms Neoadjuvant Therapy | Drug: S-1 Drug: 5-FU | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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Drug: S-1
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.
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Drug: 5-FU
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

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Disease characteristic:
- Histologically confirmed primary breast cancer by core biopsy (Mammotome or bard needle)
- Disease stage appropriate for neoadjuvant chemotherapy (T≥3cm, N0 or T(2-3cm)N1 or any T, N2)
- Her-2(-); Ki67≥14%
- No previous treatment for breast cancer (chemotherapy, endocrinotherapy, radiotherapy)
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Patients characteristic:
- Female patients, age 18 to 70 years old
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy of at least 12 weeks
- Willing to be kept follow-up
- Functions below are maintained in major organs:
- Cardiac status:
LVEF: 50% 45% • Haematopoietic status: Leukocyte count: ≥4.0×109/L Neutrophil count: ≥2.0×109/L Platelet count: ≥100×109/L Hemoglobin: ≥80g/L
• Hepatic status: Total Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 times ULN(no liver metastasis) bilirubin:
• Renal status: BUN ≤ 1.5 x times ULN Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥50 mL/min; Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
• Written informed consent (both biopsy and neoadjuvant chemotherapy) will be obtained for patients for entering this study
Exclusion Criteria:
- Previous treatment for breast cancer (neither local nor systemic therapy)
- Known or suspected distant metastasis
- Potentially pregnant, pregnant, or breast-feeding
- Drug allergy
- Concurrent malignancy or history of other malignancy (except Hodgkin lymphoma)
- Currently active severe infection (Hepatitis included)
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures
- Known history of uncontrolled severe heart disease, myocardial infarction within 6 months, congestive heart failure, unstable angina pectoris, clinically significant hydropericardium or unstable arrhythmias

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): NCT01849380
Contact: Gang Z Yu, Dr; PhD | +86 0531-85875048 | yzg@medmail.com.cn |
China, Shandong | |
the Second Hospital of Shandong Universtity | |
Jinan, Shandong, China, 250033 | |
Contact: Gang Z Yu, Dr; PhD +86 0531-85875048 yzg@medmail.com.cn | |
Principal Investigator: Gang Z Yu, Dr; PhD |
Principal Investigator: | Gang Z Yu, Dr; PhD | The Second Hospital of Shandong University |
Responsible Party: | Yu-Zhi Gang, Director of Department of Breast Disease, Shandong University |
ClinicalTrials.gov Identifier: | NCT01849380 |
Other Study ID Numbers: |
BEST T-01 |
First Posted: | May 8, 2013 Key Record Dates |
Last Update Posted: | May 8, 2013 |
Last Verified: | May 2013 |
Local Advanced Breast Neoplasms Neoadjuvant Chemotherapy S-1 |
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |