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

Phase 2CompletedNCT00198237

Indiana University40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

docetaxel & capecitabineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Indiana University Cancer Center

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

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.

Data from ClinicalTrials.gov

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