Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

Air Force Military Medical University of People's Liberation Army

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: docetaxel and epirubicin

Drug: docetaxel and epirubicin plus endostatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00604435

XOBCR01 (Other Grant/Funding Number)

Endostar B-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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