Abiraterone Acetate in Molecular Apocrine Breast Cancer

Exclusion Criteria

• •Male breast cancer;
• •HER2-positive status (positivity defined as IHC3+ and/or FISH amplification \>2.2);
• •Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin; patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for ≥ 5 years and patient is deemed to be at low risk for recurrence;
• •Active brain metastases or leptomeningeal disease; History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain;
• •Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk;
• •Significant cardiovascular disease, including any of the following:
• •1. NYHA class III-IV congestive heart failure;
• •2. Unstable angina pectoris or myocardial infarction within the past 6 months;
• •3. Severe valvular heart disease;
• •4. Ventricular arrhythmia requiring treatment.
• •Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included;
• •Patients with known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisone, or their excipients;
• •Persistent toxicities ≥ grade 2 from any cause, except chemotherapy-induced alopecia and Grade 2 peripheral neuropathy;
• •Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy;
• •Any gastrointestinal disorder interfering with absorption of the study drug;
• •Difficulties with swallowing study capsules;
• •Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy (CT) within the last 3 weeks (2 weeks for oral or weekly CT ; 6 weeks for nitrosoureas and mitomycin C), or other investigational agents ; Concurrent palliative radiotherapy allowed;
• •Concurrent enrolment in another clinical trial in which investigational therapies are administered;
• •Pregnant women, women who are likely to become pregnant or are breast-feeding;
• •Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
• •Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol;
• •Individual deprived of liberty or placed under the authority of a tutor.