Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01849380
Other study ID # BEST T-01
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05558917 - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery N/A
Active, not recruiting NCT03664778 - Abbreviated Breast MRI After Cancer Treatment
Recruiting NCT03144622 - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed NCT05452499 - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae N/A
Active, not recruiting NCT04568902 - Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Phase 1
Completed NCT02860585 - Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation N/A
Completed NCT04059809 - Photobiomodulation for Breast Cancer Radiodermatitis Phase 2/Phase 3
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Completed NCT03698942 - Delphinus SoftVue™ ROC Reader Study
Completed NCT00092950 - Exercise in Women at Risk for Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Not yet recruiting NCT02151071 - The Breast Surgery EnLight and LightPath Imaging System Study Phase 1/Phase 2
Recruiting NCT02934360 - TR(ACE) Assay Clinical Specimen Study N/A
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT02931552 - Nuevo Amanecer II: Translating a Stress Management Program for Latinas N/A
Not yet recruiting NCT02876848 - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study) N/A
Recruiting NCT02547545 - Breast Cancer Chemotherapy Risk Prediction Mathematical Model N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Completed NCT02303366 - Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475 Phase 1
Completed NCT02518477 - Preventive Intervention Against Lymphedema After Breast Cancer Surgery N/A