At a glance
ClinicalIndex Comparison Record- ✓Postmenopausal women
- ✓Histologically confirmed measurable locally advanced or metastatic breast cancer
- ✓Appropriate to receive endocrine therapy as treatment for advanced disease
- ✓Prior adjuvant chemotherapy, antiestrogens (non-aromatase inhibitors), or tamoxifen permitted; prior first-line metastatic tamoxifen or trastuzumab permitted
- ✕Known CNS metastases
- ✕Prior therapy with temsirolimus (CCI-779)
- ✕Prior therapy with aromatase inhibitors
- ✕Tamoxifen or other hormonal therapy in metastatic or adjuvant setting within 1 week prior to day 1 of treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized Open-Label Study Of Letrozole In Combination With Two Dose Levels And Schedules Of Oral Temsirolimus (CCI-779), Or Letrozole Alone, In Postmenopausal Women With Locally Advanced Or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Letrozole / Temsirolimus (CCI-779) and Letrozole for Breast Neoplasms. Completed, enrolled 108 participants.
Detailed Summary
To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.
Study Details
Timeline
Interventions
Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily
Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks
Letrozole 2.5 mg daily