Breast Cancer Acute Leukemia Lymphomas (Hodgkin and non-Hodgkin) Sarcomas (Osteo, Soft tissue and Ewing)
Conditions
Interventions
Trade Name: Pamorelin
Product Name: Pamorelin
Pharmaceutical Form: Powder and solvent for prolonged-release suspension for injection
Pharmaceutical form of the placebo: Injection
Route of administrat
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent • Age 14-42 years at cancer diagnosis • Female subjects with breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for disease-specific chemotherapy • Confirmed menarche • ECOG performance status 0-1 • Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must not be included in the study if any of the following criteria are met: • Ongoing treatment with GnRHa at baseline • Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data • Previous or planned bilateral oophorectomy • Pregnancy or breastfeeding at time of start of chemotherapy • Other malignancy diagnosed within the last five years • Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia • Known osteoporosis • Known refractory thrombocytopenia in subjects with acute leukemias • Known or suspected allergy against Pamorelin • Direct radiation of the gonads previous or planned (Total body irradiation allowed) • Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without Gonadotropin-Releasing Hormone agonist (GnRHa) by determination of the Anti-Müllerian Hormone (AMH) at 12 months after end of gonadotoxic chemotherapy (EoT) in women with breast cancer. ;Secondary Objective: Key secondary objective: To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH at 12 months after EoT in women with acute leukemias, lymphomas and sarcomas Secondary objectives: To estimate the changes in ovarian reserve with or without GnRHa by determination of the antral follicle counts in women with breast cancer, acute leukemias, lymphomas and sarcomas To estimate the changes in ovarian reserve with or without GnRHa by longitudinal observation of AMH levels in women with breast cancer, acute leukemias, lymphomas and sarcomas To compare the proportion of females with or without GnRHa that develop ovarian insufficiency by determination of FSH, inhibin and estradiol To investigate the impact of BMI, use of contraceptives and endocrine adjuvant therapy in changes of ovarian reserve with or without GnRHa by longitudinal observation of AMH levels, FSH, inhibin and estradiol, etc. ;Primary end point(s): The difference in recovery of AMH levels at follow-up 12 months after EoT, relative to AMH levels at EoT, as compared between the GnRHa group and the placebo group in women with breast cancer. ;Timepoint(s) of evaluation of this end point: At follow-up 12 months after EoT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint: The difference in recovery of AMH levels at follow-up 12 months after EoT, relative to AMH levels at EoT, between the GnRHa group and the placebo group in women with acute leukemias, lymphomas and sarcomas Secondary endpoints: • Comparison of antral follicle counts measured by ultrasound at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: o In women with breast cancer o In women with acute leukemias, lymphomas and sarcomas • The difference in recovery of AMH levels at 6 months, and follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: o In women with breast cancer o In women with acute leukemias, lymphomas and sarcomas • Comparison of FSH, inhibin and estradiol performed at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: o In women with breast cancer o In women with acute leukemias, lymphomas and sarcomas • Comparison of blood flow to the ovarian artery at baseline (right and left Doppler flow PI, RI) at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: o In women with breast cancer o In women with acute leukemias, lymphomas and sarcomas • Comparison of the proportion that develop amenorrhea (no menstruations) at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT, between the GnRHa group and the placebo group: o In women with breast cancer o In women with acute leukemias, lymphomas and sarcomas • Investigation of the impact of BMI, use of contraceptives and endocrine adjuvant therapy in changes of ovarian reserve with or without GnRHa by longitudinal observation of AMH levels, FSH, inhibin and estradiol at standardized timepoints • Comparison of of pregnancy wish, pregnancy atte | — |
Countries
Sweden
Contacts
Public ContactStudy Director
Karolinska University Hospital
Outcome results
None listed