Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00604435
First received: January 16, 2008
Last updated: January 18, 2010
Last verified: January 2010
  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 enhance the cytotoxic activity in breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel and epirubicin
Drug: docetaxel and epirubicin plus endostatin
Phase 2

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 II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • clinical/pathological response [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety and tolerability [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 69
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chemotherapy
neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin
Drug: docetaxel and epirubicin
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 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: chemotherapy plus endostatin
neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin plus endostatin
Drug: docetaxel and epirubicin plus endostatin
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 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: recombinant human endostatin, Simcere Co. China

Detailed Description:

This is an open labelled, prospective, randomized, phase II clinical trial. A total of 60 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 secondary endpoint is (1) the safety and tolerability of the regimens, (2) the role of mammography, CEUS, MRA and PET for response evaluation, and (3) angiogenic profile and biological information involved in tumor response.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604435

Locations
China, Shaanxi
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Ling Wang, MD Xijing Hospital, Fourth Military Medical University
Study Chair: Jianghao Chen, MD, PhD Xijing Hospital, Fourth Military Medical University
  More Information

Additional Information:
Publications:
Responsible Party: Dai-Ming Fan, Principal of Fourth Military Medical University, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT00604435     History of Changes
Other Study ID Numbers: Endostar B-01, XOBCR01
Study First Received: January 16, 2008
Last Updated: January 18, 2010
Health Authority: China: Food and Drug Administration

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

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 July 23, 2014