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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epirubicin-cyclophosphamide-S-1( ECS) | Experimental | 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 followed by a 14-day rest, combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly. |
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| Epirubicin-cyclophosphamide-5-FU (ECF) | Active Comparator | 5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively), combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Tolerability and safety |
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Inclusion Criteria:
Disease characteristic:
Patients characteristic:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Z Yu, Dr; PhD | Contact | +86 0531-85875048 | yzg@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Z Yu, Dr; PhD | The Second Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Hospital of Shandong Universtity | Jinan | Shandong | 250033 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 5-FU | Drug | 5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively), |
|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |