Invasive breast cancer in women under 40 years MedDRA version: 16.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: NOLVADEX
Product Name: NOLVADEX
Product Code: RVG 09592
Pharmaceutical Form: Tablet
INN or Proposed INN: TAMOXIFEN
CAS Number: 10540-29-1
Concentration unit: mg milligram(s)
Concentration
Sponsors
INSTITUT DE CANCEROLOGIE DE L'OUEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Obtention signed informed consent before any specific procedure to test 2.Age between 18 and 40 years 3.Carcinome histologically proven infiltrating breast 4.Indication adjuvant or neoadjuvant chemotherapy validated pretreatment RCP 5.T0-T1-T2-T3 6.N0-N1-N2a 7.M0 after staging according to the recommendations of the INCA 8.Statut BRCA indifferent 9.AMH = 1 ng / mL and / or = 5 CFA (ultrasound: punctionable ovaries transvaginal) 10.sérologie negative HIV social 11.Protection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Antécédents Breast Cancer 2.Antécédent other cancer in the last five years, with the exception of skin cancer basal cell and squamous cell Loading 3.Grossesse Pulmonary 4.Embolie less than 6 months Deep vein 5.Thrombose less than 6 months 6.Démence or altered mental status 7.Incapacité legal or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent (Article L.1121-6-8 L.1211, L.1211-9).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the feasibility of combining tamoxifen ovarian stimulation to recombinant FSH and oocyte vitrification and / or embryo freezing prior chemotherapy for breast cancer.;Secondary Objective: -Estimate the average time before the start of chemotherapy -Assess the impact of the type of stimulation on the number and quality of oocytes and / or embryos collected (phase of the cycle at the beginning of stimulation) Check-impact of ovarian stimulation procedure on recurrence and survival for 5 years -Determine the number of pregnancies -Descriptive analysis of the above parameters in women who accepted the preservation of fertility ;Primary end point(s): the number of oocytes and / or embryos per patient included;Timepoint(s) of evaluation of this end point: 2.5 years after the beginning of the inclusions (2 years for inclusions and 6 months to recover the data) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time in days between the day of consultation with the oncologist and the day of the first treatment - Number of positive beta hCG and number of clinical pregnancies achieved - Evaluation of survival and recurrence for 5 years - Descriptive analysis of parameters in women with accepted conservation and fertility;Timepoint(s) of evaluation of this end point: at the end or study ; after 5 ans of follow up, after recovering all data | — |
Countries
France
Contacts
Public ContactDRCI
INSTITUT DE CANCEROLOGIE DE L'OUEST
Outcome results
None listed