drugset / Trial / NCT01035099

RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF

NCT01035099

Phase 4 Completed 41 enrolled Weill Medical College of Cornell University
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare two different ways to administer Letrozole to determine their effectiveness in blocking estrogen production during ovarian stimulation in patients with breast cancer prior to chemotherapy/radiotherapy so that oocytes or embryos can be cryopreserved and patients can possibly achieve a pregnancy after the treatment of breast cancer. During standard ovulation stimulation, the estrogen levels will exceed normal levels and may reach 10 times the normal level for a 2 week period. This may not be desirable in breast cancer patients. The study hopes to determine if the investigators can stimulate oocyte development in the conventional way and administer different doses of Letrozole as the oocytes develop, to keep estradiol levels low, increase the number of oocytes the investigators are able to recover, and improve the quality of those oocytes.

Timeline

Start
2009-11
Primary completion
2019-07-23
Completion
2022-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Letrozole Other / unclassified 2.5 mg Oral
Comparator Letrozole Other / unclassified 5 mg Oral
Comparator Letrozole Other / unclassified 7.5 mg Oral