Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

Xijing Hospital69 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breast Cancer

Interventions

docetaxel and epirubicinDRUG

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

docetaxel and epirubicin plus endostatinDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

clinical/pathological response

Time frame: one year

Secondary Outcomes

safety and tolerability

Time frame: one year

Data from ClinicalTrials.gov

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