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Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer (CBCRT01)

This study is currently recruiting participants.
Verified November 2011 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01479036
First received: October 26, 2011
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further benefit breast cancer patients.


Condition Intervention Phase
Breast Cancer
 Drug: docetaxel and epirubicin
Drug: docetaxel and epirubicin plus endostatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase Ⅲ Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Clinical/pathological response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The clincial response will be evaluated according to RECIST criteria. The parameters of tumor metabolism and blood supply, as demonstrated by PET, MRA and CEUS, will be collected and analysed.


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The number of participants with adverse events will be recorded and analysed.

  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Quality of life is scored using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Questionnaire (QLQ30) at study entry and prior to surgery.

  • Number of adverse events reported during neoadjuvant therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The adverse events during neoadjuvant therapy will be graded using the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0.


Estimated Enrollment: 800
Study Start Date: October 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: docetaxel and epirubicin
DE chemotherapy alone
 Drug: docetaxel and epirubicin
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, totally 3 cycles
Other Names:
  • Docetaxel, Sanofi-Aventis
  • Epirubicin, Pfizer
Experimental: docetaxel and epirubicin plus endostatin
chemotherapy plus endostatin
 Drug: docetaxel and epirubicin plus endostatin
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; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles
Other Name: Endostatin, Simcere-Medgenn (No. S20050088)

Detailed Description:

This is a multicenter, prospective, randomized, controlled phase Ⅲ clinical trial. A total of 800 patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated with neoadjuvant systemic therapy are eligible for entry into this study. Patients will be allocated randomly to two groups to receive either 3 cycles of neoadjuvant DE and endostar or 3 cycles of neoadjuvant DE. All cases receive mammography, contrast-enhanced ultrasound (CEUS), magnetic resonance angiography (MRA), and positron emission tomography (PET) scanning pre- and post-neoadjuvant therapy, and then undergo surgical resection. The primary endpoint is clinical/pathological response. The clinical response will be evaluated according to RECIST criteria. The parameters of tumor metabolism and blood supply, as demonstrated by PET, MRA and CEUS, will be collected and analysed. The secondary endpoint is (1) the number of participants with adverse events, (2) quality of life scores, and (3) the number of adverse events reported during neoadjuvant therapy. In addition, the role of mammography, CEUS, MRA and PET for response evaluation, as well as the angiogenic profile and biological information involved in tumor response will be investigated.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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)
  • Stage ⅡA-ⅢC
  • Age 18-70
  • ECOG performance status 0-2
  • No evidence of distant metastasis
  • No previous therapy
  • Normal hematologic function
  • left ventricular ejection fraction greater than 50 percent
  • 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.
  • History of bleeding diathesis
  • Being pregnant or nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479036

Contacts
Contact: Jianghao Chen, MD, PhD 86-29-84775271 chenjh@fmmu.edu.cn
Contact: Qing Yao, MD 86-29-84775271 huanhuan@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Aidong Wen, MD     86-29-84775475 ext 8037     adwen-2004@hotmail.com    
Principal Investigator: Jianghao Chen, MD, PhD            
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Jianghao Chen, MD, PhD Xijing Hospital
Study Director: Ling Wang, MD Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01479036     History of Changes
Other Study ID Numbers: Endostar B-02, CBCRT01
Study First Received: October 26, 2011
Last Updated: November 21, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
breast cancer
neoadjuvant chemotherapy
recombinant human endostatin (endostar)
docetaxel
epirubicin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Docetaxel
Endostatins
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013