CTIS2024-516282-37-00Active, not recruitingPhase 1
Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer (PRESAGE) - ICO-N-2013-03
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •1.Obtaining signed informed consent prior to any trial-specific procedure, 10.Social protection, 2.Between 18 and 40 yo, 3.Histologically proven invasive breast carcinoma, 4.Indication for adjuvant or neoadjuvant chemotherapy validated by pre-therapy PCR, 5.T0-T1-T2-T3, 6.N0-N1-N2a, 7.M0 after extension assessment according to French INCa recommendations, 8.AMH (anti-müllerian hormone) =1 ng/mL and/or AFC (antral follicle count) = 5 (on ultrasound: ovaries puncturable transvaginally),, 9.HIV serology negative
Exclusion Criteria
- •1.Previous breast cancer, 2.History of any other cancer in the last 5 years, with the exception of basal cell and squamous cell skin cancers, 3.Pregnancy in progress, 4.Pulmonary embolism less than 6 months old, 5.Deep vein thrombosis less than 6 months old, 6.Dementia or altered mental state, 7.Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the subject from understanding the study and signing the consent form (art. L.1121-6, L.1211-8, L.1211-9).
Investigators
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