Study on the Neoadjuvant Use of Chemotherapy and Celecoxib Therapy in Patients With Invasive Breast Cancer

Exclusion Criteria

• •Male patients
• •Patients with distant metastasis, including skin involvement beyond the breast area. Patients with ulceration, erythema and infiltration of the skin (complete fixation), inflammatory breast cancer or peau d'orange (edema) of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration and patients with these conditions are eligible.)
• •Patients with ipsilateral lymph nodes that are clinically fixed to one another or to other structures (N2 disease).
• •Patients with a mass in the opposite breast, which is suspicious for malignancy, unless there is biopsy proof that the mass is not malignant.
• •Patients with multiple, bilateral breast cancer or suspicious palpable nodes in the contralateral axilla or patients with palpable supraclavicular or infraclavicular nodes, unless there is biopsy proof that the nodes are not involved with malignancy.
• •Postmenopausal patients with both positive estrogen and progesterone receptor status and negative lymph node involvement.
• •Patients with prior history of invasive breast cancer; patients with ipsilateral new cancer/recurrence after treatment of in-situ breast cancer; or patients who have received prior therapy for breast cancer, including chemotherapy, immunotherapy, hormonal therapy or radiation therapy.
• •Patients who have received any prior anthracycline or docetaxel therapy for any malignancy.
• •Patients with serious cardiac illness or medical conditions including, but not confined to:
• •* History of documented congestive heart failure (CHF);
• •* High-risk uncontrolled arrhythmias;
• •* Angina pectoris requiring antianginal medication;
• •* Clinically significant valvular heart disease;
• •* Evidence of transmural infarction on ECG; or
• •* Poorly controlled hypertension (e.g. systolic \> 180mmHg or diastolic greater than 100mmHg).
• •Patients with any abnormalities in the ECG, e.g., ventricular hypertrophy, even if they demonstrate adequate ventricular function by echocardiogram.
• •Patients with active or chronic documented infection at the time of registration.
• •Patients with pre-existing peripheral neuropathy (grade 2 or greater according to National Cancer Institute Adverse Event \[NCI AE\] v 3.0) and patients under risk of developing peripheral neuropathy, i.e., poorly controlled diabetes mellitus.
• •Patients with rheumatic disease and patients under cyclooxygenase-2 inhibitor medication.
• •Patients who are hepatitis B and/or hepatitis C carriers.
• •Patients with known hypersensitivity or contraindication to any study or pre- medications or products formulated in polysorbate 80.
• •Patients judged by the investigator to be unfit to be enrolled into the study.