Follitropin alfa for Breast cancer

Inclusion criteria

• {"criterion_text":"- Women with newly diagnosed histological proven breast cancer (whatever the grade, size, nodal status, histological type, HR and HER2 status)"}
• {"criterion_text":"- Aged from 18 to 38 years old"}
• {"criterion_text":"- Planned adjuvant chemotherapy Standard sequential anthracycline and taxane based chemotherapy (according to local practices) +/- Trastuzumab +/- Hormonotherapy"}
• {"criterion_text":"- No prior chemotherapy"}
• {"criterion_text":"- Affiliated to a public health insurance program"}
• {"criterion_text":"- Signed informed consent form"}
• {"criterion_text":"- ADDITIONAL ELIGIBILITY CRITERIA FOR COH : Sufficient ovarian reserve (i-e AMH≥ 6 pmol/l or AFC ≥ 6 follicles)"}

Exclusion criteria

• {"criterion_text":"- Metastatic breast cancer"}
• {"criterion_text":"- Planned neo-adjuvant chemotherapy"}
• {"criterion_text":"- Hysterectomy"}
• {"criterion_text":"- Exclusive adjuvant hormonotherapy"}
• {"criterion_text":"- Positive serology for syphilis, hepatitis B or C, or VIH"}
• {"criterion_text":"- Contraindication related to use of r-FSH: primary gonadal failure (primary amenorrhea), ovarian tumor, tumor of the uterus , pituitary or hypothalamus , vaginal bleeding cause undetermined , ovarian cysts or enlarged ovaries, not related to polycystic ovary syndrome, malformation of genitalia incompatible with pregnancy, uterine myomas incompatible with pregnancy"}
• {"criterion_text":"- Pregnant or breastfeeding patients"}
• {"criterion_text":"- Unable for medical follow-up (geographic, social or mental reasons)"}

Primary endpoints

• {"endpoint_text":"- Quality of the oocyte retrieval will be evaluated in terms of numbers of Meta II oocytes that can be vitrified","definition_or_measurement_approach":"Measured as the total number of Meta II oocytes that can be vitrified (number of mature oocytes retrieved) or embryos preserved relative to total oocytes/embryos."}

Secondary endpoints

• {"endpoint_text":"- Quality of oocyte and embryo retrieval will also be evaluated in terms of: • Total number of embryos and oocytes preserved • Rate of top quality embryos • Number of mature, immature and atretic oocytes","definition_or_measurement_approach":"Counts and rates: total number of embryos and oocytes preserved; proportion of top quality embryos; counts of mature, immature and atretic oocytes."}
• {"endpoint_text":"- The ovarian reserve at study entry will be described in terms of AMH level and Antral Follicle Count (AFC). A patient will be classified as eligible for the controlled ovarian stimulation (second part of the study) if the ovarian reserve is sufficient, defined as AMH≥ 6 pmol/l or AFC ≥ 6 follicles.","definition_or_measurement_approach":"Serum AMH measurement and ultrasound Antral Follicle Count (AFC); eligibility threshold AMH ≥ 6 pmol/l or AFC ≥ 6 follicles."}
• {"endpoint_text":"- Safety of the study procedures shall be evaluated over the month following the egg retrieval and judged on the NCI-CTCAE scale, version 4.0, and in terms of suggestive clinical, ultrasound and/or biological signs requiring at least an additional visit to the reproductive medicine center.Hyperstimulation syndrome (OHSS) will be graded according to Delvigne criteria. after the end of standard chemotherapy adverse events related to the study procedures will be reported.","definition_or_measurement_approach":"Adverse events graded by NCI-CTCAE v4.0 during the month following egg retrieval; OHSS graded by Delvigne criteria; longer-term AEs related to procedures reported after chemotherapy."}
• {"endpoint_text":"- The impact of the fertility preservation program on the schedule of anti-cancer treatment will be evaluated in terms of the time interval between surgery and the start of chemotherapy. A delayed start of chemotherapy is defined as a time interval greater than 60 days from the date of surgery. If chemotherapy is started more than 74 days after surgery, this will be considered as protocol deviation.","definition_or_measurement_approach":"Measured interval (days) between surgery date and chemotherapy start; delay >60 days = delayed start; >74 days = protocol deviation."}
• {"endpoint_text":"- Gonadotoxicity of chemotherapy will be evaluated AMH level and AFC, and in terms of chemotherapy-induced amenorrhea defined as a time interval from last periods greater than 90 days. Premature ovarian failure and chemotherapy-induced definitive menopause are defined as a time interval from last periods greater than 1 year and 2 years, respectively.","definition_or_measurement_approach":"Longitudinal AMH and AFC measurements; amenorrhea defined as >90 days since last period; premature ovarian failure >1 year; definitive menopause >2 years."}
• {"endpoint_text":"- All pregnancies will be reported with the type of pregnancy (spontaneous versus assisted pregnancy without or with frozen gametes) and the pregnancy outcome (miscarriage or live birth, single or multiple) over a 10–year period after the end of chemotherapy or until 43 years old","definition_or_measurement_approach":"Pregnancy incidence and outcomes collected over 10 years post-chemotherapy or until participant reaches age 43; classification of spontaneous vs assisted (with/without frozen gametes) and outcome recorded."}
• {"endpoint_text":"- Disease-free survival is defined as the time interval from the date of surgery until the date of the first relapse (locoregional or metastasic recurrence) or death from any cause. Data will be censored at last follow-up visit for patients alive free of disease","definition_or_measurement_approach":"Time-to-event analysis: interval from surgery to first relapse or death; censoring at last follow-up for disease-free patients."}
• {"endpoint_text":"- OPTIONAL TRANSLATIONAL RESEARCH (ONLY IN LILLE AND MONTPELLIER) Circulating nucleic acids quantification: - Circulating miRNAs will be extracted from serum samples and then they will be quantified by quantitative real-time RT-PCR. - Quantification of cell-free DNA in serum samples will be performed by quantitative real-time PCR.","definition_or_measurement_approach":"Quantification of circulating miRNAs by qRT-PCR and cell-free DNA by quantitative real-time PCR (exploratory ancillary study in specified sites)."}

France

Earliest CTIS Part Ii Submission Date

11-06-2024

Latest Decision Or Authorization Date

31-01-2025

Processing Time Days

234

Number Of Sites

24

Number Of Participants

139

Primary sponsor

Full Name

Centre Oscar Lambret

Organisation Type

Pharmaceutical company

Country Of Registered Address

France