Phase II Study on the Neoadjuvant Use of Chemotherapy and Celecoxib Therapy in Patients With Invasive Breast Cancer
- The patient must be free of psychiatric or addictive disorders and mentally able to
follow prescription instructions and able to give written informed consent. The
patient must consent to be in the study and must sign an approved consent form
conforming to institutional guidelines.
- The patient must be aged 18 years or older.
- The diagnosis of invasive adenocarcinoma of the breast must be confirmed by core or
Tru-cut biopsy and the interval between initial histological diagnosis of breast
cancer and registration must not be more than 1 month.
- The primary tumor within the breast must be palpable and measurable on clinical
examination and ultrasound, and must be confined to one breast. For patients with
clinically negative axillary nodes, the primary tumor size must be between 2 to 7 cm.
For patients with clinically positive axillary nodes, any primary tumor size up to 7
cm is acceptable (T2-3, N0, M0 or T1-3, N1, M0).
- ECOG performance status of 0-1 or a corresponding Karnofsky performance status of at
- Within one month prior to the time of registration, the patient must have had the
following: history, physical examination, blood tests, tumor estrogen and
progesterone receptor status assessment, chest X-ray, bone scan, abdominal
ultrasound, bilateral mammogram, and electrocardiogram (ECG).
- Hematology parameters: white blood cell (WBC) at least 2500/mm3; neutrophil count at
least 2,000/mm3; platelet count at least 100,000/mm3; and hemoglobin at least 10g/dL.
Other laboratory parameters: total serum bilirubin not exceeding 2 times
institutional upper limit of normal (ULN); AST not exceeding 2 times ULN; ALT not
exceeding 2 times ULN; alkaline phosphatase not exceeding 2 times ULN; and serum
creatinine not exceeding 2 times ULN. In borderline cases, inclusion into the study
is left to the judgment of the principal investigator.
- The patient must have adequate ventricular function with left ventricular ejection
fraction (LVEF) not less than 55% by echocardiogram scan.
- Patients with prior non-breast malignancies are eligible if they have been disease
free for more than 5 years and if they have not received any chemotherapy,
immunotherapy, hormonal therapy or radiation therapy within the last 5 years.
Patients with curatively treated non-melanoma skin cancer and carcinoma in situ of
the cervix are eligible even if diagnosed within the last 5 years prior to
- Patients receiving any sex hormonal therapy e.g., birth control pills, ovarian
hormonal replacement therapy, etc., are eligible if such therapy is discontinued 1
month prior to registration.
- 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.
- Pregnant women or women with suspected pregnancy at the time of registration and
lactating women are not eligible for the study.
- 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
- Patients with serious cardiac illness or medical conditions including, but not
- 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
- 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
- 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.