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ACTIVE NOT RECRUITING
NCT03731845
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 36 Years

Study Type

INTERVENTIONAL

Enrollment

73

Start Date

2019-04-01

Completion Date

2027-01

Last Updated

2025-11-20

Healthy Volunteers

No

Conditions

Interventions

GENETIC

Blood sample for genetic test

Patients will be genotyped for single nucleotide polymorphism previously found to be associated with age at natural menopause

BIOLOGICAL

Blood sample for hormonal measurement

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

OTHER

Ovarian ultrasound scan

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

Locations (1)

Antoine Béclère Hospital

Clamart, France