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

Indiana University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: docetaxel & capecitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00198237

0211-27

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)