Breast Cancer
Conditions
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
Interventions
PROCEDUREConsultation
Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine
BIOLOGICALBiological Test
Blood test: * FSH, LH, E2 and AMH * 4 tubes of 7 mL
PROCEDUREPelvic Ultrasound
Antral Follicles Count
Sponsors
Centre Oscar Lambret
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of fertility in terms of cumulative incidence of long-term pregnancy | 10 years after chemotherapy | for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of fertility in terms of cumulative incidence of births | 10 years after chemotherapy | separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation |
| Assessment of fertility - number of pegnancies spontaneous versus assisted | 10 years after chemotherapy | describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes) |
| Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately | 10 years after chemotherapy | describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation |
| Assessment of the number of patient willing to re-exploit their frozen gametes | 10 years after chemotherapy | for patients who have had Controlled Ovarian Hyperstimulation |
| Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate | 10 years after chemotherapy | in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation |
| Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count | 10 years after chemotherapy | in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation |
| Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse | After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy | Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence |
Countries
France
Contacts
STUDY_DIRECTORAudrey MAILLIEZ, MD
Centre Oscar Lambret
STUDY_DIRECTORChristine DECANTER, MD
Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre
Outcome results
None listed