- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01849380
Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer
Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Gang Z Yu, Dr; PhD
- Phone Number: +86 0531-85875048
- Email: yzg@medmail.com.cn
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250033
- the Second Hospital of Shandong Universtity
-
Contact:
- Gang Z Yu, Dr; PhD
- Phone Number: +86 0531-85875048
- Email: yzg@medmail.com.cn
-
Principal Investigator:
- Gang Z Yu, Dr; PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
5 years
|
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
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gang Z Yu, Dr; PhD, The Second Hospital of Shandong University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEST T-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Neoplasms
-
Emory UniversityEisai Inc.TerminatedBreast Cancer | Breast Neoplasms | Breast Tumors | Neoplasms, Breast | Cancer of the Breast | Tumors, BreastUnited States
-
Seagen Inc.CompletedTriple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast NeoplasmsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Celgene CorporationTerminatedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
Dana-Farber Cancer InstituteConquer Cancer FoundationRecruitingBreast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | HER2-positive Breast Cancer | Inflammatory Breast Cancer | Hormone Receptor Positive Malignant Neoplasm of BreastUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
GlaxoSmithKlineCompletedNeoplasms, BreastUnited States, Spain, Israel, Canada, Belgium, United Kingdom, France, Tunisia
-
GlaxoSmithKlineCompletedNeoplasms, BreastUnited States, Canada, Germany, Spain, Taiwan, Belgium, Philippines, Israel, Hong Kong, Thailand, Pakistan, Russian Federation, Italy, Romania, China, France, Peru, United Kingdom, Czech Republic, Australia, Chile, Korea, Republic of and more
-
MedSIRHoffmann-La RocheCompletedAdvanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast CancerSpain, France, United Kingdom, Germany, Italy
Clinical Trials on S-1
-
Tomoshi TsuchiyaCompleted
-
Fudan UniversityThe First Affiliated Hospital of Anhui Medical University; Guangdong Provincial... and other collaboratorsWithdrawn
-
Peking University Cancer Hospital & InstituteRecruiting
-
Sun Yat-sen UniversityUnknown
-
Zhejiang Cancer HospitalCompleted
-
Taiho Oncology, Inc.Quintiles, Inc.; United BioSource, LLCCompletedLocally Advanced or Metastatic Pancreatic Cancer
-
TTY BiopharmNational Taiwan University Hospital; Chang Gung Memorial Hospital; Taipei Veterans... and other collaboratorsTerminatedPancreatic Cancer | Adjuvant Chemotherapy | Resected Pancreatic CancerTaiwan
-
Fudan UniversityCompletedNasopharyngeal CarcinomaChina
-
Seoul National University Bundang HospitalUnknown
-
Japan Clinical Cancer Research OrganizationKitasato UniversityCompleted