A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer

NCT ID: NCT01907529

Last Updated: 2019-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stage III Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemo plus Endostar

Docetaxel, epirubicin and cyclophosphamide plus endostar

Group Type EXPERIMENTAL

docetaxel, epirubicin and cyclophosphamide plus endostar

Intervention Type DRUG

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

Chemo only

docetaxel, epirubicin and cyclophosphamide

Group Type ACTIVE_COMPARATOR

docetaxel, epirubicin and cyclophosphamide

Intervention Type DRUG

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

Interventions

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docetaxel, epirubicin and cyclophosphamide

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

docetaxel, epirubicin and cyclophosphamide plus endostar

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University Fourth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yunjiang Liu

M.D, Chief Physician of Breast Cancer Dept, Vice-President of Hebei Medical University Fourth Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YUNJIANG LIU, M.D.& PhD.

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Locations

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Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Other Identifiers

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HBMUFH-101

Identifier Type: -

Identifier Source: org_study_id

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