- Postmenopausal women with histologically confirmed, measurable locally advanced
disease or metastatic breast.
- Must be appropriate to receive endocrine therapy as treatment for advanced disease
(chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase
inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or
trastuzumab, are permitted).
- Women may either present with de novo advanced or metastatic cancer, or have had tumor
progression while receiving adjuvant tamoxifen or at any time after completing
adjuvant tamoxifen, or have had tumor progression while receiving first-line
metastatic therapy with tamoxifen.
- Patients having known central nervous system (CNS) metastases.
- Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.
- Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1
week prior to day 1 of treatment on study.