Study on Androgen Receptor and Triple Negative Breast Cancer

Exclusion Criteria

• •1. 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;
• •3. 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 Magnetic resonance Imaging (MRI) of the brain;
• •4. Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk;
• •5. Significant cardiovascular disease, including any of the following:
• •1. NYHA class III-IV congestive heart failure
• •2. Stroke, unstable angina pectoris or myocardial infarction within the past 6 months
• •3. Severe valvular heart disease
• •4. Ventricular arrhythmia requiring treatment;
• •6. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included;
• •7. Persistent toxicities grade ≥2 from any cause, except chemotherapy-induced alopecia and grade 2 peripheral neuropathy;
• •8. Any gastrointestinal disorder interfering with absorption of the study drug;
• •9. Difficulties with swallowing tablets;
• •10. An active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment;
• •11. PREVIOUS TREATMENT IN THE METASTATIC SETTING: Previous treatment with: capecitabine (MET SETTING), first generation (bicalutamide) or second-generation AR inhibitors (enzalutamide, ARN-509, darolutamide) or other investigational AR inhibitors CYP17 enzyme inhibitor such as abiraterone (capecitabine in the adjuvant setting is allowed provided the last administration was at least ≥12 months prior to study entry)
• •12. Patients with known deficit of dihydropyrimidine dehydrogenase (DPD) activity; or in case of hypersensitivity to capecitabine or to any of its excipients or to fluorouracil;
• •13. Prior anticancer therapy within the last 3 weeks including radiotherapy, endocrine therapy, immunotherapy; chemotherapy (6 weeks for nitrosoureas and mitomycin C), or other investigational agents; concurrent palliative radiotherapy is allowed;
• •14. Concurrent enrolment in another clinical trial in which investigational therapies are administered;
• •15. Pregnant women, women who are likely to become pregnant or are breast-feeding;
• •16. 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;
• •17. Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol;
• •18. Individual deprived of liberty or placed under the authority of a tutor.