Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604435
• Other study ID #: Endostar B-01
• Secondary ID: XOBCR01
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2008
• Last updated: January 18, 2010
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)

• Stage ?A-?C

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel and epirubicin
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 endostatin
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

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Li J, Dong X, Xu Z, Jiang X, Jiang H, Krissansen GW, Sun X. Endostatin gene therapy enhances the efficacy of paclitaxel to suppress breast cancers and metastases in mice. J Biomed Sci. 2008 Jan;15(1):99-109. Epub 2007 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical/pathological response		one year	No
Secondary	safety and tolerability		one year	Yes

External Links

•   By far, endostatin has not been used for the treatment of breast cancer patients in either adjuvant or neoadjuvant settings. This article reported endostatin gene therapy enhances the efficacy of taxane to suppress breast cancer and metastases in mice.