- Subjects who received neo-adjuvant/adjuvant therapy and now present with newly relapsed advanced or metastatic disease are eligible; however, prior neo-adjuvant/adjuvant therapy is not required for study entry; 11. Subjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP, [Premarin]), at least 1 month (30 days) prior to receiving the first dose of randomized therapy;