Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation
- Conditions
- Breast Cancer
- Interventions
- Procedure: Controlled ovarian hyperstimulation (COH)Procedure: Oocyte/embryo freezing
- Registration Number
- NCT02871167
- Lead Sponsor
- Centre Oscar Lambret
- Brief Summary
The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.
- Detailed Description
Medical Oncology:
* Information and collection of consent,
* Imaging staging,
* Inclusion
* Physical examination
* Contraception advise given
Reproductive medicine center:
* Ovarian reserve assessment: serum anti-mullerian hormone (AMH) measurement and antral follicle count (AFC) by ultrasound.
* Serology syphilis, hepatitis B and C, HIV (human immunodeficiency virus). In case of embryo cryopreservation, same serology determination for the men.
* Infertility risk and fertility preservation techniques information.
* In case of agreement, this technique will be done during the time-interval between surgery and chemotherapy
* Fertility preservation (COH stimulation, triggering and oocyte retrieval)
Adjuvant chemotherapy:
* The chemotherapy regimen is 3 FEC (fluorouracil epirubicin cyclophosphamide) 100 followed by standard chemotherapy (according to local practice) +/- Trastuzumab. Adjuvant chemotherapy may only begin after the oocyte retrieval.
* Usual adjuvant chemotherapy is not changed
During chemotherapy:
* Clinical exam before each cycle of chemotherapy
* AMH, AFC at cycle 6
After chemotherapy:
* Usual patient monitoring in expert center :
physical examination at Month 3 (M3), M6 M9 M12 M18 and M24 and mammography at M9 then annual
* AMH at Month 3 (M3), M6 M9 M12 M18 and M24
* AFC at Month 12 (M12) and M24
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- Women with histologically proven breast cancer
- Aged 18 to 38 years old
- Planned adjuvant chemotherapy
- No prior chemotherapy
- Affiliated to a public health insurance program
- Informed consent signed by the patient
- Metastatic breast cancer
- Planned neo-adjuvant chemotherapy
- Hysterectomy
- Exclusive adjuvant hormonotherapy
- Positive serology for syphilis, hepatitis B or C, or VIH
- Contraindication related to use of r-FSH
- Pregnant or breastfeeding patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oocyte/embryo cryopreservation Oocyte/embryo freezing 1. Controlled ovarian hyperstimulation (COH) 2. Oocyte/embryo freezing Oocyte/embryo cryopreservation Controlled ovarian hyperstimulation (COH) 1. Controlled ovarian hyperstimulation (COH) 2. Oocyte/embryo freezing
- Primary Outcome Measures
Name Time Method Quality of oocytes: total number of oocytes preserved after oocyte retrieval (35-36 hours after triptorelin injection) The distribution of the total number of oocytes preserved will be summarized by the mean (standard error) and median (range) and presented with a 95% confidence interval.
- Secondary Outcome Measures
Name Time Method Rate of patients wishing for re-utilization of their frozen gametes up to 10 years after the end of the study or at 43 years old To assess the number of patients wishing for re-utilization of their frozen gametes
Type of oocytes after oocyte retrieval (35-36 hours after triptorelin injection) mature, immature, fractured
Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale 24 months Toxicities will be tabulated with frequencies and percentages by type of adverse events and by grade
Antral Follicular Count (AFC) measurement baseline, at month 3, at month 12, at month 24 Number of Spontaneous or medically assisted pregnancy(ies) up to 10 years after the end of the study or at 43 years old To measure the degree of project completion of subsequent pregnancy(ies)
Disease-free survival through study completion, an average of 5 years defined as the interval between inclusion and the first occurrence of local, regional or distant relapse, estimated using the Kaplan-Meier method
Serum AMH measurement baseline, at the end of the first sequence of chemotherapy, at the last injection of treatment, at Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24 Quality of embryos: total number of embryos preserved at 44-46 hours post intra-cell sperm injection
Trial Locations
- Locations (27)
Hôpital Antoine Béclère
🇫🇷Clamart, France
Centre François Baclesse
🇫🇷Caen, France
CHU Lyon
🇫🇷Lyon, France
Centre Léon Bérard
🇫🇷Lyon, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Aliénor d'Aquitaine, Hôpital Pellegrin
🇫🇷Bordeaux, France
Hôpital Jean Verdier
🇫🇷Bondy, France
CHU de Caen
🇫🇷Caen, France
CHU Limoges
🇫🇷Limoges, France
CHU REUNION site SUD
🇫🇷La Réunion, France
CHU La Conception
🇫🇷Marseille, France
CHRU Hôpital Jeanne de Flandres
🇫🇷Lille, France
Institut Paoli Calmette
🇫🇷Marseille, France
CHU de Dijon
🇫🇷Dijon, France
CHRU Montpellier
🇫🇷Montpellier, France
Centre Oscar Lambret
🇫🇷Lille, France
ICM - Val d'Aurelle
🇫🇷Montpellier, France
Hôpital Universitaire de Strasbourg
🇫🇷Strasbourg, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital TENON
🇫🇷Paris, France
Institut Curie
🇫🇷Saint-Cloud, France
CHRU de Nancy
🇫🇷Nancy, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre les nancy, France
Oncopole-CHU Toulouse
🇫🇷Toulouse, France
Centre Henri Becquerel
🇫🇷Rouen, France
CHU Rouen
🇫🇷Rouen, France
Centre Georges François LECLERC
🇫🇷Dijon, France