NCT00604435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

1.9 years

First QC Date

January 16, 2008

Last Update Submit

January 18, 2010

Conditions

Breast Cancer

Keywords

breast cancerneoadjuvant chemotherapydocetaxelepirubicinrecombinant human endostatin (endostar)chemotherapyendostatin

Outcome Measures

Primary Outcomes (1)

  • clinical/pathological response

    one year

Secondary Outcomes (1)

  • safety and tolerability

    one year

Study Arms (2)

chemotherapy

ACTIVE COMPARATOR

neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin

Drug: docetaxel and epirubicin

chemotherapy plus endostatin

EXPERIMENTAL

neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin plus endostatin

Drug: docetaxel and epirubicin plus endostatin

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

Also known as: docetaxel, Sanofi-Aventis, epirubicin, Pfizer
chemotherapy
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

Also known as: recombinant human endostatin, Simcere Co. China
chemotherapy plus endostatin

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

  • 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.

    PMID: 17705027BACKGROUND

  • 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.

    PMID: 23693018DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelEpirubicinEndostatins

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesAngiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological Factors

Study Officials

  • Ling Wang, MD

    Air Force Military Medical University, China

    STUDY DIRECTOR

  • Jianghao Chen, MD, PhD

    Air Force Military Medical University, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 30, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

CN(1)