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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Cancerologie de l'Ouest
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

• Aged between 18 and 40

• infiltrating breast carcinoma histologically proven

• Indication of adjuvant or neoadjuvant chemotherapy

• T0-T1-T2-T3

• N0-N1-N2a

• M0 after staging

• AMH ≥1 ng / mL and / or account antral follicles ≥ 5

• HIV serology negative.

Exclusion Criteria:

• breast cancer history

• History of another cancer in the last 5 years, with the exception of basal cell skin cancer and squamous cell

• patient in pregnancy

• pulmonary embolism under 6 months

• deep vein thrombosis of less than 6 months.