Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: filgrastim; capecitabine; celecoxib; cyclophosphamide; docetaxel; doxorubicin hydrochloride; gene expression analysis; polymorphism analysis; protein expression analysis; reverse transcriptase-polymerase chain reaction; imaging biomarker analysis; immunohistochemistry staining method; laboratory biomarker analysis; pharmacogenomic studies; dynamic contrast-enhanced magnetic resonance imaging; needle biopsy; neoadjuvant therapy; radiomammography; ultrasound imaging
Intervention MeSH terms: Celecoxib; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 19 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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