Expired Study
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Indianapolis, Indiana 46202


Purpose:

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 summary:

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.


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


NCT ID:

NCT00198237


Primary Contact:

Principal Investigator
Kathy Miller, M.D.
Indiana University


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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