Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Genomic and Proteomic Analysis of Docetaxel and Capecitabine as Primary Chemotherapy for 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Principal Investigator

Kathy Miller, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Food and Drug Administration

Study ID:

0211-27

NCT ID:

NCT00198237

Start Date:

March 2003

Completion Date:

December 2005

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • Breast Neoplasms

Name

Location
Indiana University Cancer Center Indianapolis, Indiana  46202-5265