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NCT Number: NCT00198237

Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel & capecitabine

Drug

Primary outcomes

  1. 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 outcomes

  1. To evaluate genomic and proteonomic changes after initial therapy with docetaxel & capecitabine as monotherapy after combined docetaxel & capecitabine therapy.

  2. To compare pre-treatment genomic and proteomic profiles in responders and non-responders.

  3. To compare the results of serum-based and tissue-based proteomic analyses.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Aventis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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