Skip to content

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516282-37-00
Acronym
ICO-N-2013-03
Enrollment
100
Registered
2024-08-09
Start date
2025-02-18
Completion date
Unknown
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Brief summary

The feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH as part of fertility preservation prior to chemotherapy for breast cancer will be assessed on the basis of the number of oocytes and/or embryos obtained per patient included.

Detailed description

Evaluation of the average time taken to start chemotherapy: time (in days) between the day of the consultation with the oncologist and the day of administration of the first chemotherapy treatment, Overall survival / event-free survival at 10 years., Number of pregnancies obtained: number of positive beta HCG and number of clinical pregnancies., Ancillary study (Nantes patients only): Analysis of plasma concentrations of tamoxifen and its metabolites, 4 -hydroxytamoxifen, N - desmethyltamoxifen and endoxifen

Interventions

Sponsors

Institut De Cancerologie De L Ouest
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH as part of fertility preservation prior to chemotherapy for breast cancer will be assessed on the basis of the number of oocytes and/or embryos obtained per patient included.

Secondary

MeasureTime frame
Evaluation of the average time taken to start chemotherapy: time (in days) between the day of the consultation with the oncologist and the day of administration of the first chemotherapy treatment, Overall survival / event-free survival at 10 years., Number of pregnancies obtained: number of positive beta HCG and number of clinical pregnancies., Ancillary study (Nantes patients only): Analysis of plasma concentrations of tamoxifen and its metabolites, 4 -hydroxytamoxifen, N - desmethyltamoxifen and endoxifen

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026