NCT03731845Active, not recruiting
Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 10 Aug 2018
- Start date
- 1 Apr 2019
- Primary completion date
- Oct 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- NCT number
- NCT03731845
What you commit to
- Study type: Interventional
- Participants enrolled: 73
- From 1 Apr 2019 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Intensification of chemotherapy
Who the study is looking for
- Age: 18 - 36 years
- Diagnosis of breast cancer
- BMI≤30 Kg/m2
- Baseline antral Follicular count (before initiation of chemotherapy): 10-40 follicles measuring 2 - 9 mm in diameter
- Regular and ovulatory menstrual cycles
- Indication of neoadjuvant (4 FEC and 4 docetaxel) or adjuvant (3 FEC and 3 docetaxel) chemotherapy
- Free informed and written consent, dated and signed by the patient and the investigator
- Patient affiliated to the French National Social Security System
- Non inclusion criteria
- Previous history of chemotherapy
- History of ovarian surgery or endometrioma
- Ovarian Polycystic Syndrome
- DOR or POI before chemotherapy
- Virgin patients
Age in the registry: 18 years to 36 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antoine Béclère Hospital Coordinator of this site? Confirm its status | Clamart | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.