Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer (CBCRT01)

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Drug: docetaxel and epirubicin plus endostatin; Drug: docetaxel and epirubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT01479036

Endostar B-02

CBCRT01 (Other Grant/Funding Number)

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 benefit breast cancer patients.

Full description

This is a multicenter, prospective, randomized, controlled phase Ⅲ clinical trial. A total of 800 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 clinical response will be evaluated according to RECIST criteria. The parameters of tumor metabolism and blood supply, as demonstrated by PET, MRA and CEUS, will be collected and analysed. The secondary endpoint is (1) the number of participants with adverse events, (2) quality of life scores, and (3) the number of adverse events reported during neoadjuvant therapy. In addition, the role of mammography, CEUS, MRA and PET for response evaluation, as well as the angiogenic profile and biological information involved in tumor response will be investigated.

Enrollment: 800 estimated 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

800 participants in 2 patient groups

docetaxel and epirubicin

Active Comparator group

Description:

DE chemotherapy alone

Treatment:

Drug: docetaxel and epirubicin

docetaxel and epirubicin plus endostatin

Experimental group

Description:

chemotherapy plus endostatin

Treatment:

Drug: docetaxel and epirubicin plus endostatin