Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00665457

Run by

University of Nebraska

People needed

3

Starts

2004-04-15

Expected to finish

2009-07-31

Last updated by the study team

2023-09-13

Who can join

Age: 19 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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
• Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• At least 2 weeks since prior treatment with cyclooxygenase (COX)-2 inhibitors

You may not qualify if…

• Not pregnant or nursing/negative pregnancy test
• 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
• No prior chemotherapy or radiation therapy for ipsilateral breast cancer
• No concurrent sorivudine or brivudine to treat herpes simplex or herpes zoster viral infections
• No concurrent participation in another therapeutic clinical trial

Where it is running

• Unversity of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.