NCT01199393

Brief Summary

The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

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

August 31, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

4.3 years

First QC Date

August 31, 2010

Last Update Submit

July 27, 2015

Conditions

Breast NeoplasmDrug TherapyPolymorphism,Single Nucleotide

Keywords

breast neoplasmdrug therapypolymorphismgene

Outcome Measures

Primary Outcomes (1)

  • Response to chemotherapy

    Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).

    6 months

Secondary Outcomes (3)

  • Time to disease progression

    1 year

  • Overall survival

    5 years

  • Toxicity

    6 months

Eligibility Criteria

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

female patients with metastatic breast cancer

You may qualify if:

  • Histologically confirmed metastatic breast cancer
  • Female
  • 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:

  • Central nervous system metastases
  • Serious or uncontrolled concurrent medical illness
  • History of other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

about 4ml peripheral vein blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ningning Dong, PhD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

  • Jun Jia, MD

    Peking University Cancer Hospital & Institute

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 13, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

CN(1)