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
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.
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 SurvivalTolerability and safety
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
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
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
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