Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood sample for genetic test: Patients will be genotyped for single nucleotide polymorphism previously found to be associated with age at natural menopause

Blood sample for hormonal measurement: at each visit : 2x7ml. At the end of the study hormonal measurements (AMH, P4, LH, FSH, E25)

Ovarian ultrasound scan: Ovarian ultrasound scan at follow up visits (Y1,Y1.5, Y2.5 Y3.5 Y4.5 Y5.5)

Study summary

Over the past decade, advances in diagnosis and treatments have dramatically increased the rates of cure for young patients with cancer. As a consequence, a new population of cancer survivors has emerged whose fertility is compromised after cancer therapy. Indeed, gonadotoxicity is a well-known long-term side effect of cancer treatment in young patients having survived malignant diseases. More than 80% of women of childbearing age, treated for breast cancer with standard protocol of neoadjuvant (4 cycles of 5-fluorouracile - epirubicin- cyclophosphamide (FEC) and 4 cycles of docetaxel) or adjuvant chemotherapy (3 FEC and 3 docetaxel), show an alteration of their ovarian reserve 2 years after completion of the treatment, as a result of chemotherapy-related follicular loss. Therefore, according to the extent of the follicular damages, the gonadal function may vary from moderate to severe diminished ovarian reserve (DOR) and possibly to the ultimate stage of premature ovarian insufficiency (POI).

Investigators propose a multicentric and prospective study of a cohort of young women with breast cancer to evaluate whether genetic polymorphisms, previously identified as being correlated with age at menopause in the healthy population, are associated with the intensity of the follicular decline following chemotherapy in young breast cancer survivors.

Eligibility

Primary outcome measure(s)

• Assessment of ovarian reserve — 5 years after completion of chemotherapy
  is an aggregated measure of FSH, AMH serum level, Antral Follicle Count and menstrual profile : * Normal ovarian reserve: persistence of menstrual cycle, FSH\<40 IU/L and AMH\>1.1 ng/mL or AFC\>7 follicles * Moderate diminished ovarian reserve : persistence of menstrual cycle, FSH\<40 IU/L and 0.5≤AMH≤1.1 ng/mL or 5≤AFC≤7 follicles * Severe diminished ovarian reserve : persistence of menstrual cycle and AMH\<0.5 ng/mL or AFC\<5 follicles * Premature ovarian insufficiency is defined by amenorrhea above four months and FSH level ≥40 IU/L in women before 40 years. AMH serum levels and ultrasonographic evaluation of AFC will be evaluated FIVEyears after the end of chemotherapy.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition