Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer
18 Years
70 Years
Female
Breast Cancer
Trial Information
Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
clinical/pathological response
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
Ling Wang, MD
Investigator Role:
Study Director
Investigator Affiliation:
Xijing Hospital, Fourth Military Medical University
Authority:
China: Food and Drug Administration
Study ID:
Endostar B-01
NCT ID:
NCT00604435
Start Date:
February 2008
Completion Date:
January 2010
Related Keywords:
- Breast Cancer
- breast cancer
- neoadjuvant chemotherapy
- docetaxel
- epirubicin
- recombinant human endostatin (endostar)
- chemotherapy
- endostatin
- Breast Neoplasms
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