Clinical trial NCT01849380: Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer
Official title: Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Neoplasms
Neoadjuvant Therapy
Keywords: Local Advanced Breast Neoplasms
Neoadjuvant Chemotherapy
S-1
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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, radiotherapy)
* 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

Primary outcomes:
measure: Pathological complete response
timeFrame: 12 weeks
Secondary outcomes:
measure: Disease-free Survival
timeFrame: 5 years
measure: Tolerability and safety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: the Second Hospital of Shandong Universtity
state: Shandong
Study officials:
affiliation: The Second Hospital of Shandong University
name: Gang Z Yu, Dr; PhD
role: PRINCIPAL_INVESTIGATOR
References: