Biomarkers in Women Receiving Chemotherapy and Celecoxib for Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This phase II clinical trial is studying biomarkers and side effects in women receiving chemotherapy and celecoxib for stage II or stage III breast cancer that can be removed by surgery.

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

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Celecoxib; Cyclophosphamide; Docetaxel; Doxorubicin; Lenograstim; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Pathologic evidence of invasive breast cancer

• Stage II-III disease

• Resectable disease

• Must have a primary tumor estimated by mammogram, ultrasound or palpation to be ≥ 3 cm and/or palpable axillary nodes > 1 cm for whom neoadjuvant chemotherapy is appropriate

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• ECOG performance status 0-1

• Absolute granulocyte count > 2,000/mm^3

• Platelet count > 100,000/mm^3

• Serum bilirubin < 1.5 times upper limit of normal (ULN)

• Serum creatinine < 1.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study therapy

• No allergies to sulfa medication, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)

• No uncontrolled concurrent illness that might jeopardize the patient's ability to receive the chemotherapy program outlined in this protocol, including any of the following:

• Active infection requiring intravenous antibiotics

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Serious, uncontrolled cardiac arrhythmia

• No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiation therapy for ipsilateral breast cancer.

• At least 2 weeks since prior treatment with cyclooxygenase (COX)-2 inhibitors

• No concurrent sorivudine or brivudine to treat herpes simplex or herpes zoster viral infections

• No concurrent participation in another therapeutic clinical trial