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Serum Proteomics to Predict Gemcitabine Sensitivity in Breast Cancer

NCT00212069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-12-11

No results posted yet for this study

Summary

Tumors are heterogeneous with varying response to chemotherapeutic agents. We hypothesize that tumors that are sensitive to a particular chemotherapeutic agent have a distinctive tumor protein profile compared to those that are resistant. We further hypothesize that since tumor is continuously perfused by serum, serum protein profile can be used as a surrogate marker of tumor protein profile. The primary objective of this study is to identify a serum protein profile that predicts gemcitabine/carboplatin sensitivity or resistance in breast cancer patients with prior exposure to anthracyclines and taxanes. Secondary objectives are to establish the serum protein profile of breast cancer patients who have had prior exposure to anthracyclines and taxanes, and to study the pharmacogenetics of gemcitabine toxicity by correlating germline genotype of transporters and drug metabolizing enzymes with plasma and intracellular gemcitabine pharmacokinetics.

Conditions

Interventions

DRUG

gemcitabine, carboplatin

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Soo-Chin Lee, MD · Consultant

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00212069 on ClinicalTrials.gov