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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01907529
Recruitment Status : Enrolling by invitation
First Posted : July 25, 2013
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yunjiang Liu, Hebei Medical University Fourth Hospital

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.

Condition or disease Intervention/treatment Phase
Stage III Breast Cancer Drug: docetaxel, epirubicin and cyclophosphamide Drug: docetaxel, epirubicin and cyclophosphamide plus endostar Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. Clinical/pathological response [ Time Frame: 48 months ]
    The clincial response will be evaluated according to RECIST criteria.


Secondary Outcome Measures :
  1. PFS [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907529


Locations
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China, Hebei
Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China
Shijiazhuang, Hebei, China, 050011
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: YUNJIANG LIU, M.D.& PhD. The Fourth Hospital of Hebei Medical University

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Responsible Party: Yunjiang Liu, M.D, Chief Physician of Breast Cancer Dept, Vice-President of Hebei Medical University Fourth Hospital, Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT01907529     History of Changes
Other Study ID Numbers: HBMUFH-101
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Endostar protein
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors