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

This study is currently recruiting participants. (see Contacts and Locations)
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

October 26, 2011
November 21, 2011
October 2011
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01479036 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer
Phase Ⅲ Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-Line Therapy in Patients With Breast Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Breast Cancer
  • 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
  • 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)
  • Active Comparator: docetaxel and epirubicin
    DE chemotherapy alone
    Intervention: Drug: docetaxel and epirubicin
  • Experimental: docetaxel and epirubicin plus endostatin
    chemotherapy plus endostatin
    Intervention: Drug: docetaxel and epirubicin plus endostatin
In our previous phase Ⅱ trial (NCT00604435), the combination of rh-endostatin with docetaxel and epirubicin chemotherapy resulted in a higher objective response rate without increased toxicity in breast cancer patients, as compared with chemotherapy alone. Our results have been accepted to report as General Poster in ASCO's 47th Annual Meeting in 2011. Wang L, Chen JH, Yao Q, et al. Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study. 2011 ASCO Annual Meeting Proceedings, J Clin Oncol 2011; 29(15s): 112s.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
February 2015
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact: Jianghao Chen, MD, PhD 86-29-84775271 chenjh@fmmu.edu.cn
Contact: Qing Yao, MD 86-29-84775271 huanhuan@fmmu.edu.cn
China
 
NCT01479036
Endostar B-02, CBCRT01
Yes
Xijing Hospital
Xijing Hospital
Not Provided
Principal Investigator: Jianghao Chen, MD, PhD Xijing Hospital
Study Director: Ling Wang, MD Xijing Hospital
Xijing Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP