Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Exclusion Criteria

• •c) Renal function: i) Creatinine ≤ 175 µmol/L (2 mg/dL) ii) If creatinine was 140 - 175 μmol/L, the calculated creatinine clearance should be ≥ 60 mL/min.
• •Complete staging work-up within 3 months prior to registration. All participants had bilateral mammography, chest X-ray (posterioanterior \[PA\] and lateral) and/or computerized tomography (CT) and/or magnetic resonance imaging (MRI), abdominal ultrasound and/or CT scan and/or MRI, and bone scan. In cases of positive bone scans, bone X-ray evaluation was mandatory to rule out the possibility of metastatic bone scan positivity. Other tests may be performed as clinically indicated.
• •Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
• •An audiology assessment with normal results was to be performed within 4 weeks of registration. This was only for those centers who had selected cisplatin as their platinum salt of choice for the BCIRG 006 study.
• •Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
• •Prior anthracycline therapy, taxoids (paclitaxel, docetaxel) or platinum salts for any malignancy.
• •Prior radiation therapy for breast cancer.
• •Bilateral invasive breast cancer.
• •Pregnant, or lactating participants. Participants of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must had negative urine or serum pregnancy test within 7 days prior to registration.
• •Any T4 or N2 or known N3 or M1 breast cancer.
• •Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by National Cancer Institute (NCI) criteria.
• •Cardiac disease that would preclude the use of doxorubicin, docetaxel and Herceptin:
• •1. any documented myocardial infarction
• •2. angina pectoris that required the use of antianginal medication
• •3. any history of documented congestive heart failure
• •4. Grade 3 or Grade 4 cardiac arrhythmia (NCI Common Terminology Criteria \[CTC\], version 2.0)
• •5. clinically significant valvular heart disease
• •6. participants with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG, unless they demonstrate by MUGA scan within the past 3 months that the LVEF was ≥ the lower limit of normal for the radiology facility;
• •7. participants with poorly controlled hypertension i.e. diastolic greater than 100 mm/Hg. (Participants who were well controlled on medication were eligible for entry)
• •8. participants who currently received medications (digitalis, beta-blockers, calcium channel-blockers, etc) that altered cardiac conduction, if these medications were administered for cardiac arrhythmia, angina or congestive heart failure. If these medications were administered for other reasons (ie hypertension), the participant was eligible.
• •Other serious illness or medical condition:
• •1. history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
• •2. active uncontrolled infection
• •3. active peptic ulcer, unstable diabetes mellitus
• •4. impaired hearing (only for those participants treated at centers who had selected cisplatin as their platinum salt of choice)
• •Past or current history of neoplasm other than breast carcinoma, except for:
• •1. curatively treated non-melanoma skin cancer
• •2. in situ carcinoma of the cervix
• •3. other cancer curatively treated and with no evidence of disease for at least 10 years
• •4. ipsilateral DCIS of the breast
• •5. lobular carcinoma in-situ (LCIS) of the breast
• •Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. Participants must had discontinued these agents prior to randomization.
• •Chronic treatment with corticosteroids unless initiated \> 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).
• •Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to randomization.
• •Definite contraindications for the use of corticosteroids.
• •Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
• •Concurrent treatment with any other anti-cancer therapy.
• •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.