Clinical trial NCT03795246: Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer
Official title: Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Interventional research with low risks and constraints, prospective and monocentric on the assessment of long-term fertility in patients who underwent an adjuvant sequential chemotherapy with or without a controled ovarian hyperstimulation. This study follows a previous one called NCT 01614704.

Detailed description: The patients will have a follow-up once a year during ten years beginning at the end of their chemotherapy.

They will have a consultation in oncology consisting of:

* a clinical exam,
* a collection and follow-up of oncological data
* a collection of ongoing cancer treatments

and a consultation in gynecology consisting of:

* a pelvic ultrasound scan (for AFC: Antral Follicle Count)
* a biological test (FSH, LH, E2, AMH)
* a collection of gynecological data, contraception and reproductive medicine

Eligibility criteria: Inclusion Criteria:

* Patients included in the study CT 01614704
* Informed and written consent
* Affiliated to the National Social Security System

Exclusion Criteria:

* Impossibility to submit at the study procedures due to geographic, social or mental reasons
* Patient deprived of their liberty or under guardianship or tutorship.

Primary outcomes:
measure: Assessment of fertility in terms of cumulative incidence of long-term pregnancy
timeFrame: 10 years after chemotherapy
Secondary outcomes:
measure: Assessment of fertility in terms of cumulative incidence of births
timeFrame: 10 years after chemotherapy
measure: Assessment of fertility - number of pegnancies spontaneous versus assisted
timeFrame: 10 years after chemotherapy
measure: Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately
timeFrame: 10 years after chemotherapy
measure: Assessment of the number of patient willing to re-exploit their frozen gametes
timeFrame: 10 years after chemotherapy
measure: Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate
timeFrame: 10 years after chemotherapy
measure: Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count
timeFrame: 10 years after chemotherapy
measure: Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse
timeFrame: After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Audrey MAILLIEZ, MD
role: STUDY_DIRECTOR
affiliation: Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre
name: Christine DECANTER, MD
role: STUDY_DIRECTOR
References: