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

August 7, 2019 updated by: Yunjiang Liu, Hebei Medical University Fourth Hospital

A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Chemo plus Endostar
Docetaxel, epirubicin and cyclophosphamide plus endostar
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
Active Comparator: Chemo only
docetaxel, epirubicin and cyclophosphamide
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical/pathological response
Time Frame: 48 months
The clincial response will be evaluated according to RECIST criteria.
48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Fourth Hospital

Investigators

  • Principal Investigator: YUNJIANG LIU, M.D.& PhD., The Fourth Hospital of Hebei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBMUFH-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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