At a glance
ClinicalIndex Comparison Record- ✓Confirmed histological diagnosis of breast cancer, acute leukemias, lymphomas (Hodgkin and non-Hodgkin), or sarcomas (osteo, soft tissue, Ewing)
- ✓Assigned for disease-specific chemotherapy
- ✓Confirmed menarche (menstruation has started)
- ✓ECOG performance status 0-1
- ✕Premature ovarian failure at randomization by clinical or biochemical criteria
- ✕Previous or planned bilateral oophorectomy
- ✕Pregnant or breastfeeding at chemotherapy start
- ✕Other malignancy diagnosed within last 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomised Double-Blinded Placebo-Controlled Study of Use of GnRHa During Chemotherapy for Fertility Protection of Young Women and Teenagers With Cancer
In Brief
A Phase 3 clinical trial evaluating Triptorelin Embonate and Sodium Chloride solution 0.9% for Breast Cancer Female and 5 related conditions. Currently recruiting, targeting 500 participants across 17 sites.
Detailed Summary
Many cytotoxic drugs may harm the fertility of young women treated for cancer. The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can preserve the fertility of young female cancer subjects. Approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment. The patients will be randomised in between treatment with triptorelin (experimental) or placebo (control) intramuscularly a 1:1 ratio during chemotherapy. The injections may be given once monthly or once three months depending on type of chemotherapy given. Randomisation and study drug is blinded, neither investigator, research nurse nor patient will know if it is active drug or placebo. The only person who knows is the nurse preparing the injection. Patients will be followed up to 5 years after end of treatment with physical examinations, vital signs, biochemical markers, bone mineral density exams, ultrasound for antral follicle counts and ovarian doppler flow, concomitant medications, adverse events and quality of life questionnaires.
Study Details
Timeline
Interventions
11.25 mg will be given for subjects having at least 3 months gonadotoxic treatment, one injection of 11.25 mg will compensate for 3 months' effect of the study drug. 3.75 mg will be given for subjects during one-month of gonadotoxic treatment, one injection of 3.75 mg will compensate for 1 month' effect of the study drug.
One injection compensating for 3 months' effect OR one injection compensating for 1 month' effect to maintain the study blind.