NCT01198301

Brief Summary

The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

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

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

September 9, 2010

Last Update Submit

July 22, 2015

Conditions

Breast NeoplasmsNeoplasm Metastasis

Keywords

Metastatic Breast NeoplasmsGene Expression ProfilingDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Chemotherapy response

    Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines

    four-months

Secondary Outcomes (3)

  • Time to disease progression

    six months

  • Overall survival

    one year

  • clinical benefit response

    six months to one year

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

female patients with metastatic breast cancer treated by Docetaxel-based chemotherapy

You may qualify if:

  • Patients should be histologically confirmed with metastatic breast cancer;
  • Patients who had completed the planned chemotherapy regimen with no major protocol violation;
  • an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • At least one measurable lesion;
  • Normal cardiac, hepatic, renal and bone marrow functions;
  • Life expectancy ≥3 months;
  • Discontinuity of previous chemotherapy for a minimum of 4 weeks.

You may not qualify if:

  • previous history of other malignancies;
  • previous surgery history on the needle biopsy organ;
  • Central nervous system metastases;
  • Serious or uncontrolled concurrent medical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

the tissue will be obtained by core niddle biopsy.

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zheng Wang, PhD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

  • Jun Ren, MD

    Peking University Cancer Hospital & Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 10, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CN(1)