Breast Cancer
Conditions
Keywords
oocyte/embryo cryopreservation
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
Interventions
PROCEDUREControlled ovarian hyperstimulation (COH)
After information and consent, patients are addressed to a reproductive medicine center. The COH will be performed according to a standardized protocol between surgery and the start of adjuvant chemotherapy. Follicular growth will be achieved with an antagonist protocol and by using high dose recombinant FSH (r-FSH). The triggering of the final follicular and oocyte maturation will be obtained by a GnRH (Gonadotropin Releasing Hormone) agonist injection in order to minimize the risk of ovarian hyper-stimulation.
PROCEDUREOocyte/embryo freezing
Egg or embryo freezing will be performed according to a standardized protocol: slow-freezing process for embryo; vitrification technique for oocytes. Cryopreserved oocytes and embryos will be stored in the biological bank of each reproductive medicine center (min. 10 years).
Sponsors
Centre Oscar Lambret
University Hospital, Lille
National Cancer Institute, France
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of embryos: total number of embryos preserved | at 44-46 hours post intra-cell sperm injection | — |
| 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 |
| 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 | — |
| 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) |
| 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 |
| 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 |
Countries
France
Contacts
STUDY_DIRECTORAudrey Maillez, MD
Centre Oscar Lambret
STUDY_DIRECTORChristine Decanter, MD
CHRU of Lille - Hôpital Jeanne de Flandre
Outcome results
None listed