Clinical trial · Interventional
Evaluation of Individual Sensitivity to the Gonadotoxicity of Chemotherapy in Young Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample for genetic test | Genetic | — | UNRESOLVED |
| Blood sample for hormonal measurement | Biological | — | UNRESOLVED |
| Ovarian ultrasound scan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patient
- interventionNames
- Genetic: Blood sample for genetic test
- Biological: Blood sample for hormonal measurement
- Other: Ovarian ultrasound scan
Primary outcomes (1)
- measure
- Assessment of ovarian reserve
- timeFrame
- 5 years after completion of chemotherapy
- description
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 36 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: \- Intensification of chemotherapy
References
Publications (0)
Data not yet available