Tamoxifen citrate for Breast cancer

Inclusion criteria

• {"criterion_text":"- 1.\tObtaining signed informed consent prior to any trial-specific procedure"}
• {"criterion_text":"- 10.\tSocial protection"}
• {"criterion_text":"- 2.\tBetween 18 and 40 yo"}
• {"criterion_text":"- 3.\tHistologically proven invasive breast carcinoma"}
• {"criterion_text":"- 4.\tIndication for adjuvant or neoadjuvant chemotherapy validated by pre-therapy PCR"}
• {"criterion_text":"- 5.\tT0-T1-T2-T3"}
• {"criterion_text":"- 6.\tN0-N1-N2a"}
• {"criterion_text":"- 7.\tM0 after extension assessment according to French INCa recommendations"}
• {"criterion_text":"- 8.\tAMH (anti-müllerian hormone) ≥1 ng/mL and/or AFC (antral follicle count) ≥ 5 (on ultrasound: ovaries puncturable transvaginally),"}
• {"criterion_text":"- 9.\tHIV serology negative"}

Exclusion criteria

• {"criterion_text":"- 1.\tPrevious breast cancer"}
• {"criterion_text":"- 2.\tHistory of any other cancer in the last 5 years, with the exception of basal cell and squamous cell skin cancers"}
• {"criterion_text":"- 3.\tPregnancy in progress"}
• {"criterion_text":"- 4.\tPulmonary embolism less than 6 months old"}
• {"criterion_text":"- 5.\tDeep vein thrombosis less than 6 months old"}
• {"criterion_text":"- 6.\tDementia or altered mental state"}
• {"criterion_text":"- 7.\tLegal incapacity or limited legal capacity. Medical or psychological conditions preventing the subject from understanding the study and signing the consent form (art. L.1121-6, L.1211-8, L.1211-9)."}

Primary endpoints

• {"endpoint_text":"- The feasibility of ovarian stimulation combining Tamoxifen with recombinant FSH as part of fertility preservation prior to chemotherapy for breast cancer will be assessed on the basis of the number of oocytes and/or embryos obtained per patient included.","definition_or_measurement_approach":"Measured on the basis of the number of oocytes and/or embryos obtained per patient included (count of oocytes and/or embryos per patient)."}

Secondary endpoints

• {"endpoint_text":"- Evaluation of the average time taken to start chemotherapy: time (in days) between the day of the consultation with the oncologist and the day of administration of the first chemotherapy treatment","definition_or_measurement_approach":"Defined as time in days between oncologist consultation and administration of first chemotherapy."}
• {"endpoint_text":"- Overall survival / event-free survival at 10 years.","definition_or_measurement_approach":"Overall survival and event-free survival assessed at 10 years (time-to-event analyses over 10 years)."}
• {"endpoint_text":"- Number of pregnancies obtained: number of positive beta HCG and number of clinical pregnancies.","definition_or_measurement_approach":"Count of pregnancies: number of positive beta HCG tests and number of clinically confirmed pregnancies."}
• {"endpoint_text":"- Ancillary study (Nantes patients only): Analysis of plasma concentrations of tamoxifen and its metabolites, 4 -hydroxytamoxifen, N - desmethyltamoxifen and endoxifen","definition_or_measurement_approach":"Quantitative plasma concentration analysis of tamoxifen and listed metabolites in subset of Nantes patients."}

France

Earliest CTIS Part Ii Submission Date

08-07-2024

Latest Decision Or Authorization Date

09-08-2024

Processing Time Days

32

Number Of Sites

8

Number Of Participants

100

Primary sponsor

Full Name

Institut De Cancerologie De L Ouest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France