Clinical trial NCT02871167: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation
Official title: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: oocyte/embryo cryopreservation
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: National Cancer Institute, France
name: University Hospital, Montpellier
First posted: 2016-08-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Quality of oocytes: total number of oocytes preserved
timeFrame: after oocyte retrieval (35-36 hours after triptorelin injection)
Secondary outcomes:
measure: Quality of embryos: total number of embryos preserved
timeFrame: at 44-46 hours post intra-cell sperm injection
measure: Type of oocytes
timeFrame: after oocyte retrieval (35-36 hours after triptorelin injection)
measure: Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale
timeFrame: 24 months
measure: Serum AMH measurement
timeFrame: 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
measure: Antral Follicular Count (AFC) measurement
timeFrame: baseline, at month 3, at month 12, at month 24
measure: Number of Spontaneous or medically assisted pregnancy(ies)
timeFrame: up to 10 years after the end of the study or at 43 years old
measure: Rate of patients wishing for re-utilization of their frozen gametes
timeFrame: up to 10 years after the end of the study or at 43 years old
measure: Disease-free survival
timeFrame: through study completion, an average of 5 years
Other outcomes:
measure: Translational research : circulating nucleic acids quantification: cell-free DNA and microRNAs on blood sample
timeFrame: an average of 6 months
Locations:
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Bordeaux
country: France
facility: Centre Aliénor d'Aquitaine, Hôpital Pellegrin
city: Caen
country: France
facility: CHU de Caen
city: Caen
country: France
facility: Centre François Baclesse
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Dijon
country: France
facility: Centre Georges François LECLERC
city: Dijon
country: France
facility: CHU de Dijon
city: La Réunion
country: France
facility: CHU REUNION site SUD
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU Hôpital Jeanne de Flandres
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: CHU Lyon
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: CHU La Conception
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: CHRU Montpellier
city: Montpellier
country: France
facility: ICM - Val d'Aurelle
city: Nancy
country: France
facility: CHRU de Nancy
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital TENON
city: Rouen
country: France
facility: CHU Rouen
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Cloud
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: Hôpital Universitaire de Strasbourg
city: Toulouse
country: France
facility: Oncopole-CHU Toulouse
city: Vandoeuvre les nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Oscar Lambret
name: Audrey Maillez, MD
role: STUDY_DIRECTOR
affiliation: CHRU of Lille - Hôpital Jeanne de Flandre
name: Christine Decanter, MD
role: STUDY_DIRECTOR
References: