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

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ClinicalTrials.gov Identifier: NCT00198237
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : June 3, 2014
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Indiana University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel & capecitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genomic and Proteomic Analysis of Docetaxel and Capecitabine as Primary Chemotherapy for Stage II-III Breast Cancer
Study Start Date : March 2003
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198237


Locations
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United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Aventis Pharmaceuticals
Investigators
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Principal Investigator: Kathy Miller, M.D. Indiana University

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ClinicalTrials.gov Identifier: NCT00198237     History of Changes
Other Study ID Numbers: 0211-27
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014
Keywords provided by Indiana University:
Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites