A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer
TENDENCY
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2013
CompletedFirst Posted
Study publicly available on registry
July 25, 2013
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 9, 2019
August 1, 2019
1 year
July 22, 2013
August 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical/pathological response
The clincial response will be evaluated according to RECIST criteria.
48 months
Secondary Outcomes (1)
PFS
5 years
Study Arms (2)
Chemo plus Endostar
EXPERIMENTALDocetaxel, epirubicin and cyclophosphamide plus endostar
Chemo only
ACTIVE COMPARATORdocetaxel, epirubicin and cyclophosphamide
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China
Shijiazhuang, Hebei, 050011, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YUNJIANG LIU, M.D.& PhD.
Hebei Medical University Fourth Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D, Chief Physician of Breast Cancer Dept, Vice-President of Hebei Medical University Fourth Hospital
Study Record Dates
First Submitted
July 22, 2013
First Posted
July 25, 2013
Study Start
August 1, 2019
Primary Completion
August 1, 2020
Study Completion
December 1, 2021
Last Updated
August 9, 2019
Record last verified: 2019-08