Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

Terminated

• Conditions: Ovarian Reserve

• Registration Number: NCT01114464
• Lead Sponsor: Nantes University Hospital

Brief Summary

The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations and after during follow-up (24 months). This strategy offers 2 main advantages : no modification of the traditional care of patients (treatment, organisation, follow up ...) and use of a non invasive marker (serum). The final objective is to give precise information to patients on their future fertility after remission.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-05
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• female 18-39 years
• suffering from breast cancer
• treated with adjuvant or neoadjuvant chemotherapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients	24 months	Serum anti-Müllerian hormone concentration will be measured at each chemotherapy administration and 24 months follow-up after chemotherapy completion

Trial Locations

Locations (11)

Centre François BACLESSE; 🇫🇷 Caen, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Val d'Aurelle - Paul Lamarque; 🇫🇷 Montpellier, France

Institut Bergonié; 🇫🇷 Bordeaux, France

CRLC de Bourgogne Georges François Leclerc; 🇫🇷 Dijon, France

Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau; 🇫🇷 Saint Herblain, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre de Lutte Contre le Cancer Léon Bérard; 🇫🇷 Lyon, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Institut Curie; 🇫🇷 Paris, France