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Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

Information source: Shandong University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms; Neoadjuvant Therapy

Intervention: S-1 (Drug); 5-FU (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Shandong University

Official(s) and/or principal investigator(s):
Gang Z Yu, Dr; PhD, Principal Investigator, Affiliation: The Second Hospital of Shandong University

Overall contact:
Gang Z Yu, Dr; PhD, Phone: +86 0531-85875048, Email: yzg@medmail.com.cn


S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine drug consisting of i M tegafur (FT), 0. 4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity. Several studies have proved the safety and efficacy of single agent S-1 in metastatic breast cancer. This study is designed to further investigate and compare the efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs. Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients with local advanced breast cancer.

Clinical Details

Official title: Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pathological complete response

Secondary outcome:

Disease-free Survival

Tolerability and safety


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.


Inclusion Criteria:

- 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,


- 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

Locations and Contacts

Gang Z Yu, Dr; PhD, Phone: +86 0531-85875048, Email: yzg@medmail.com.cn

the Second Hospital of Shandong Universtity, Jinan, Shandong 250033, China; Not yet recruiting
Gang Z Yu, Dr; PhD, Phone: +86 0531-85875048, Email: yzg@medmail.com.cn
Gang Z Yu, Dr; PhD, Principal Investigator
Additional Information

Starting date: June 2013
Last updated: May 6, 2013

Page last updated: August 23, 2015

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