A Phase 2 interventional study of Letrozole in Postmenopausal Women With Advanced Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 12 sites in Japan. Open to female participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 31 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion / exclusion criteria may apply.
Drug: Letrozole
Also known as: FEM345
Safety during treatment
Time frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
Response Rate during treatment
Time frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks
Time frame: Maximum 28 weeks after initiate treatment
Plasma estrogens level at baseline and at every 4 weeks until 28 weeks
Time frame: Maximum 28 weeks after initiate treatment
Duration of response
Time frame: From the first date of response confirmed and the last date of response confirmed
Time to progression
Time frame: From the first date of response confirmed and the last date of response confirmed
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals