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Phase II Trial for Large ER-Negative Breast Cancers

NCT01869192 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-09-24

Study results available
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Summary

A primary objective of this study is to evaluate the in vivo response of tumor to chemotherapy through gene microarray analysis. Neoadjuvant treatment allows the unique opportunity to observe the in vivo effects of cytotoxic therapy on gene expression in tumor tissue. The investigators plan to evaluate several different questions by comparing gene profiles in different phases of treatment in this study. These are outlined below.

Hypotheses

1. Chemotherapy enriches for tumor cell populations that have enhanced resistance and survival mechanisms. These mechanisms will in part be identifiable through changes in gene expression profiles pre vs. post treatment.
2. Use of two distinct chemotherapy selection pressures, for example a DNA-damaging regimen (epirubicin and cyclophosphamide) or a mitotic spindle/metabolic targeted regimen (docetaxel and capecitabine), will allow for the identification of a smaller set of genes associated to resistance and survival mechanisms of broad importance.
3. Genes associated with enrichment for resistance and survival mechanisms will not be present in large amounts pretreatment in tumors destined for complete pathologic response.

Conditions

  • Malignant Neoplasm of Female Breast

Interventions

DRUG

Epirubicin

Epirubicin 90 mg/m2 d1 q3w

DRUG

Cyclophosphamide

Cyclophosphamide 600 mg/m2 d1 q3w

DRUG

Docetaxel

Docetaxel 75 mg/m2 d1 q3w

DRUG

Capecitabine

Capecitabine 1000 mg/m2/dose bid x 14d q3w

RADIATION

Radiation Therapy

Standard dosing, fields depending on clinical findings

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Anthony Elias, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-05
Primary Completion
2009-12-18
Completion
2010-08-21

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01869192 on ClinicalTrials.gov