Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer

May 30, 2014 updated by: Indiana University School of Medicine

Genomic and Proteomic Analysis of Docetaxel and Capecitabine as Primary Chemotherapy for Stage II-III Breast Cancer

The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemo for subjects w/ stage II-III breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemotherapy for subjects with stage II-III breast cancer.Subjects will be randomized into one of two groups: Docetaxel followed by four cycles of docetaxel & capecitabine vs. capecitabine followed by four cycles of docetaxel and capecitabine.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the breast w/ Stage II-III disease w/ a primary tumor >/=2cm or clinically palpable axillary lymph nodes.
  • Pre-treatment core or incisional bx w/ adequate tissue for histology & genomic/proteomic analysis.
  • Primary tumor must be bi-dimensionally measurable by physical exam or dx breast imaging. Measurements must be obtained w/in 3 wks prior to study entry.
  • Adequate organ fxn:AGC>1500; Hb>/=9.0;plts>/=100K; Crt</=2.0;Cacl Crt Clr>/=50; total bili</=ULN; LFTs<2.0 ULN
  • ECOG performance status 0-1
  • Neg. pregnancy test

Exclusion Criteria:

  • Pts may not have had definitive primary surgery.
  • Metastatic breast cancer
  • Any prior chemo or hormonal therapy for breast cancer
  • Prior history of malignancy w/in the previous 5 yrs.
  • No active unresolved infection
  • No major surgery w/in 2wks of start of study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemotherapy for subjects with stage II-III breast cancer.

Secondary Outcome Measures

Outcome Measure
To evaluate genomic and proteonomic changes after initial therapy with docetaxel & capecitabine as monotherapy after combined docetaxel & capecitabine therapy.
To compare pre-treatment genomic and proteomic profiles in responders and non-responders.
To compare the results of serum-based and tissue-based proteomic analyses.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Kathy Miller, M.D., Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

June 3, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0211-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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