NCT01198301

Completed

Gene Expression Profiling of Metastatic Breast Cancer Predic...

Peking University Cancer Hospital & Institute Source

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Other study identifiers

Sponsor study identifier

GEP

Study Type

observational

Actual enrollment (reported)

42

Locations

1 country

Sites

1

Timeline

Study Start

August 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2012

Actual (reported)

Study Completion

July 2012

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 42 participants
Study completion date: July 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 9, 2010
Actual (reported)
First Posted
September 10, 2010
Actual (reported)
Primary Completion
July 2012
Actual (reported)
Study Completion
July 2012
Actual (reported)

Last Updated: July 23, 2015
Status Verified: July 2015
Last Update Submitted: July 22, 2015

Conditions

Breast Neoplasms Neoplasm 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;

Sponsors & Collaborators

Peking University Cancer Hospital & Institute
Otherlead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

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

Enrollment

42 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

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NCT00067314

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Phase 2Completed

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.

Primary Completion

July 2012

Actual (reported)

Study Completion

July 2012

Actual (reported)

Last Updated

July 23, 2015

Record last verified: 2015-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01198301
Data provider: ClinicalTrials.gov
Source updated: 2015-07-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:58 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations