Neoadjuvant Endostatin and Chemotherapy for Breast Cancer

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ClinicalTrials.gov Identifier: NCT00604435

Recruitment Status : Completed

First Posted : January 30, 2008

Last Update Posted : January 20, 2010

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Sponsor:

Information provided by:

Xijing Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: docetaxel and epirubicin Drug: docetaxel and epirubicin plus endostatin	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	69 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer
Study Start Date :	February 2008
Actual Primary Completion Date :	January 2010
Actual Study Completion Date :	January 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Epirubicin hydrochloride Epirubicin Docetaxel

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: chemotherapy 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 Other Names: docetaxel, Sanofi-Aventis epirubicin, Pfizer
Experimental: chemotherapy plus endostatin 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 Other Name: recombinant human endostatin, Simcere Co. China

Outcome Measures

Primary Outcome Measures :

clinical/pathological response [ Time Frame: one year ]

Secondary Outcome Measures :

safety and tolerability [ Time Frame: one year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604435

Locations

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

Sponsors and Collaborators

Xijing Hospital

Investigators

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Study Director:	Ling Wang, MD	Air Force Military Medical University, China
Study Chair:	Jianghao Chen, MD, PhD	Air Force Military Medical University, China

More Information

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. doi: 10.1007/s11373-007-9201-3. Epub 2007 Aug 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen J, Yao Q, Li D, Zhang J, Wang T, Yu M, Zhou X, Huan Y, Wang J, Wang L. Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study. BMC Cancer. 2013 May 21;13:248. doi: 10.1186/1471-2407-13-248.

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Responsible Party:	Dai-Ming Fan, Principal of Fourth Military Medical University, Fourth Military Medical University
ClinicalTrials.gov Identifier:	NCT00604435
Other Study ID Numbers:	Endostar B-01 XOBCR01 ( Other Grant/Funding Number: Natural Science Foundation of Shaanxi Province (2008K09-06) )
First Posted:	January 30, 2008 Key Record Dates
Last Update Posted:	January 20, 2010
Last Verified:	January 2010

Keywords provided by Xijing Hospital:


breast cancer neoadjuvant chemotherapy docetaxel epirubicin	recombinant human endostatin (endostar) chemotherapy endostatin

Additional relevant MeSH terms:

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Endostatins Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel Epirubicin Antineoplastic Agents Tubulin Modulators Antimitotic Agents	Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors

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