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A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer (TENDENCY)

H

Hebei Medical University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Stage III Breast Cancer

Treatments

Drug: docetaxel, epirubicin and cyclophosphamide
Drug: docetaxel, epirubicin and cyclophosphamide plus endostar

Study type

Interventional

Funder types

Other

Identifiers

NCT01907529
HBMUFH-101

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Chemo plus Endostar
Experimental group
Description:
Docetaxel, epirubicin and cyclophosphamide plus endostar
Treatment:
Drug: docetaxel, epirubicin and cyclophosphamide plus endostar
Chemo only
Active Comparator group
Description:
docetaxel, epirubicin and cyclophosphamide
Treatment:
Drug: docetaxel, epirubicin and cyclophosphamide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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