Breast Cancer
Conditions
Keywords
Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Brief 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.
Detailed 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.
Interventions
DRUGdocetaxel & capecitabine
Sponsors
Aventis Pharmaceuticals
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate genomic and proteonomic changes after initial therapy with docetaxel & capecitabine as monotherapy after combined docetaxel & capecitabine therapy. | — |
| To compare pre-treatment genomic and proteomic profiles in responders and non-responders. | — |
| To compare the results of serum-based and tissue-based proteomic analyses. | — |
Countries
United States
Outcome results
None listed