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

Breast Cancer Clinical Trial

Official title:

Genomic and Proteomic Analysis of Docetaxel and Capecitabine as Primary Chemotherapy for Stage II-III Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198237
• Other study ID #: 0211-27
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2005
• Last updated: May 30, 2014
• Start date: March 2003
• Est. completion date: December 2005

Study information

• Verified date: May 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel & capecitabine

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate genomic and proteonomic changes after initial therapy with docetaxel & capecitabine as monotherapy after combined docetaxel & capecitabine therapy.
Secondary	To compare pre-treatment genomic and proteomic profiles in responders and non-responders.
Secondary	To compare the results of serum-based and tissue-based proteomic analyses.