Breast Neoplasms, Neoadjuvant Therapy
Conditions
Keywords
Local Advanced Breast Neoplasms, Neoadjuvant Chemotherapy, S-1
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.
Interventions
DRUGS-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
DRUG5-FU
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | 5 years | 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 |
| Tolerability and safety | 12 weeks | 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 |
Countries
China
Contacts
Primary ContactGang Z Yu, Dr; PhD
Outcome results
None listed