drugset / Trial / NCT02890082

Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer

NCT02890082

Phase 2 Active not recruiting 102 enrolled Institut Cancerologie de l'Ouest
Non-randomizedParallel-groupOpen-labelOther

Summary

The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments. Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment. PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer. The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic. This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.

Timeline

Start
2014-02
Primary completion
2017-07-17
Completion
2028-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamoxifen Small molecule 60 mg
Background Cetrorelix Other / unclassified
Background FSH Unknown 150 iu
Background FSH Unknown 300 iu
Background Ovidrel Protein / enzyme biologic 250 ug