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

Phase 2
18 Years
70 Years
Not Enrolling
Breast Cancer

Thank you

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

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:


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:


Principal Investigator

Ling Wang, MD

Investigator Role:

Study Director

Investigator Affiliation:

Xijing Hospital, Fourth Military Medical University


China: Food and Drug Administration

Study ID:

Endostar B-01



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