 - HORMONE REFRACTORY: Patients with ERPR-positive disease according to ASCO-CAP guidelines above may be considered if they have disease progression after two lines of hormonal therapy administered in the adjuvant or metastatic setting, or are deemed clinically hormone-resistant taking into consideration the rate of progression of disease or a short interval of time on first line hormonal therapy before progression. Clinically hormone-resistant patients MUST also be discussed with the Study Chair, Study co-Chair or designee in advance for approval. 