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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Collaborator: Aventis Pharmaceuticals
• Treatments: Capecitabine; Docetaxel

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/=50; total bili
• 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