Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Consultation
* Biological: Biological Test
* Procedure: Pelvic Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Process<br>Consultation, Biological Test, Pelvic Ultrasound | Procedure: Consultation<br>* Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine<br>Biological: Biological Test<br>* Blood test: FSH, LH, E2 and AMH 4 tubes of 7 mL<br>Procedure: Pelvic Ultrasound<br>* Antral Follicles Count<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of fertility in terms of cumulative incidence of long-term pregnancy | for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation | 10 years after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of fertility in terms of cumulative incidence of births | separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation | 10 years after chemotherapy | 
| Assessment of fertility - number of pegnancies spontaneous versus assisted | describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes) | 10 years after chemotherapy | 
| Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately | describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation | 10 years after chemotherapy | 
| Assessment of the number of patient willing to re-exploit their frozen gametes | for patients who have had Controlled Ovarian Hyperstimulation | 10 years after chemotherapy | 
| Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate | in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation | 10 years after chemotherapy | 
| Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count | in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation | 10 years after chemotherapy | 
| Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse | Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence | After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy |