Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01849380
• Other study ID #: BEST T-01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 6, 2013
• Last updated: May 6, 2013
• Start date: June 2013
• Est. completion date: June 2018

Study information

• Verified date: May 2013
• Source: Shandong University
• Contact: Gang Z Yu, Dr; PhD
• Phone: +86 0531-85875048
• Email: yzg[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 2018
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoadjuvant Therapy

Intervention

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
• 5-FU
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),

Locations

Country	Name	City	State
China	the Second Hospital of Shandong Universtity	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response	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.	12 weeks	No
Secondary	Disease-free Survival	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	5 years	No
Secondary	Tolerability and safety	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	12 weeks	Yes