Neoadjuvant Endostatin and Chemotherapy for Breast Cancer - Full Text View

Sponsor:	Xijing Hospital
Information provided by:	Xijing Hospital
ClinicalTrials.gov Identifier:	NCT00604435

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: docetaxel and epirubicin Drug: docetaxel and epirubicin plus endostatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Epirubicin hydrochloride Epirubicin Docetaxel Endostatin

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:

clinical/pathological response [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and tolerability [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment:	69
Study Start Date:	February 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
chemotherapy: Active Comparator neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin	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
chemotherapy plus endostatin: Experimental neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin plus endostatin	Drug: 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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604435

Locations

China, Shaanxi
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Xijing Hospital

Investigators

Study Director:	Ling Wang, MD	Xijing Hospital, Fourth Military Medical University
Study Chair:	Jianghao Chen, MD, PhD	Xijing Hospital, Fourth Military Medical University

More Information

Additional Information:

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Fourth Military Medical University ( Dai-Ming Fan, Principal of Fourth Military Medical University )
Study ID Numbers:	Endostar B-01, XOBCR01
Study First Received:	January 16, 2008
Last Updated:	January 18, 2010
ClinicalTrials.gov Identifier:	NCT00604435 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Xijing Hospital:

breast cancer
neoadjuvant chemotherapy
docetaxel
epirubicin

recombinant human endostatin (endostar)
chemotherapy
endostatin

Additional relevant MeSH terms:

Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms
Endostatins
Antibiotics, Antineoplastic
Epirubicin
Angiogenesis Inhibitors

Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010