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

Phase 4
18 Years
70 Years
Not Enrolling
Breast Neoplasms, Neoadjuvant Therapy

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Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Pathological complete response

Outcome Description:

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.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Gang Z Yu, Dr; PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

the second hospital of Shandong University


China: Food and Drug Administration

Study ID:




Start Date:

June 2013

Completion Date:

June 2018

Related Keywords:

  • Breast Neoplasms
  • Neoadjuvant Therapy
  • Local Advanced Breast Neoplasms
  • Neoadjuvant Chemotherapy
  • S-1
  • Breast Neoplasms
  • Neoplasms