MedTrace Logo

Validate Gene Expression and Proteomic Signatures Predictive of Treatment for Response for Breast Cancer Patient

NCT00669773 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2013-12-10

No results posted yet for this study

Summary

Primary Objectives

1. Validate our previously generated tumor gene expression and proteomic profiles in this independent sample to determine the predictive power to distinguish good from poor clinical and pathological responders to adriamycin or docetaxel.
2. Validate our previously generated plasma proteomic profiles in this independent sample to determine the predictive power to distinguish good from poor clinical and pathological responders to adriamycin and docetaxel.

Secondary objectives

1. To correlate adriamycin and docetaxel pharmacokinetics with

1. Genetic polymorphisms of drug metabolizing enzymes and transporters, including MDR-1, Cyp3A, GSTs, and the nuclear receptors.
2. Drug toxicity and tumor response.
3. Peripheral mononuclear cell gene expression profiles
2. To study ondansetron pharmacokinetics and correlate that with genetic polymorphisms.

Conditions

Interventions

DRUG

Adriamycin

Arm A: 4 cycles of adriamycin at 75mg/m2 3 weekly followed by surgery followed by 4 cycles of docetaxel at 75mg/m2 3 weekly

DRUG

Docetaxel

Arm B: 4 cycles of docetaxel at 75mg/m2 3 weekly followed by surgery followed by 4 cycles of adriamycin at 75mg/m2 3 weekly.

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Soo Chin LEE, MBBS, MRCP · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
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 NCT00669773 on ClinicalTrials.gov