Back to resultsA Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer (TENDENCY)
Primary Purpose
Stage III Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
docetaxel, epirubicin and cyclophosphamide
docetaxel, epirubicin and cyclophosphamide plus endostar
Sponsored by
About this trial
This is an interventional treatment trial for Stage III Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
- Age 18-70
- No evidence of distant metastasis
- No previous therapy
- Normal hematologic function
- No abnormality of renal or liver function
- Written informed consent
Exclusion Criteria:
- With allergic constitution or possible allergic reflection to drugs to be used in this study
- Any concurrent uncontrolled medical or psychiatric disorder
- History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
- Being pregnant or nursing
Sites / Locations
- Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chemo plus Endostar
Chemo only
Arm Description
Docetaxel, epirubicin and cyclophosphamide plus endostar
docetaxel, epirubicin and cyclophosphamide
Outcomes
Primary Outcome Measures
Clinical/pathological response
The clincial response will be evaluated according to RECIST criteria.
Secondary Outcome Measures
PFS
Full Information
NCT ID
NCT01907529
First Posted
July 22, 2013
Last Updated
August 7, 2019
Sponsor
Hebei Medical University Fourth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01907529
Brief Title
A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer
Acronym
TENDENCY
Official Title
A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University Fourth Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemo plus Endostar
Arm Type
Experimental
Arm Description
Docetaxel, epirubicin and cyclophosphamide plus endostar
Arm Title
Chemo only
Arm Type
Active Comparator
Arm Description
docetaxel, epirubicin and cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
docetaxel, epirubicin and cyclophosphamide
Intervention Description
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; totally 4 cycles
Intervention Type
Drug
Intervention Name(s)
docetaxel, epirubicin and cyclophosphamide plus endostar
Intervention Description
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostar 7.5mg/m2, IV (in the vein) from day 1 to day 14, totally 4 cycles
Primary Outcome Measure Information:
Title
Clinical/pathological response
Description
The clincial response will be evaluated according to RECIST criteria.
Time Frame
48 months
Secondary Outcome Measure Information:
Title
PFS
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
Age 18-70
No evidence of distant metastasis
No previous therapy
Normal hematologic function
No abnormality of renal or liver function
Written informed consent
Exclusion Criteria:
With allergic constitution or possible allergic reflection to drugs to be used in this study
Any concurrent uncontrolled medical or psychiatric disorder
History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
Being pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YUNJIANG LIU, M.D.& PhD.
Organizational Affiliation
The Fourth Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer
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