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Trial record 2 of 5 for:    Tegafur AND DPYD

Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT01849380
Recruitment Status : Unknown
Verified May 2013 by Yu-Zhi Gang, Shandong University.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2013
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):
Yu-Zhi Gang, Shandong University

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Neoadjuvant Therapy Drug: S-1 Drug: 5-FU Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer
Study Start Date : June 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Epirubicin-cyclophosphamide-S-1( ECS)
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.
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
Other Name: SuLi, QILU Pharmaceutical co.ltd

Active Comparator: Epirubicin-cyclophosphamide-5-FU (ECF)
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.
Drug: 5-FU
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),




Primary Outcome Measures :
  1. Pathological complete response [ Time Frame: 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 Outcome Measures :
  1. Disease-free Survival [ Time Frame: 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


  2. Tolerability and safety [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849380


Contacts
Contact: Gang Z Yu, Dr; PhD +86 0531-85875048 yzg@medmail.com.cn

Locations
China, Shandong
the Second Hospital of Shandong Universtity Not yet recruiting
Jinan, Shandong, China, 250033
Contact: Gang Z Yu, Dr; PhD    +86 0531-85875048    yzg@medmail.com.cn   
Principal Investigator: Gang Z Yu, Dr; PhD         
Sponsors and Collaborators
Shandong University
Investigators
Principal Investigator: Gang Z Yu, Dr; PhD The Second Hospital of Shandong University

Responsible Party: Yu-Zhi Gang, Director of Department of Breast Disease, Shandong University
ClinicalTrials.gov Identifier: NCT01849380     History of Changes
Other Study ID Numbers: BEST T-01
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by Yu-Zhi Gang, Shandong University:
Local Advanced Breast Neoplasms
Neoadjuvant Chemotherapy
S-1

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors