Breast Cancer FemalePhase 3ProFertilNCT05328258
Use of GnRHa During Chemotherapy for Fertility Protection
A Phase 3 study testing Triptorelin Embonate and Sodium Chloride solution 0.9% in people with Breast Cancer Female and Acute Leukemia, run by Kenny Rodriguez-Wallberg at 17 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 42 years, women only
- Conditions the study is for
- Breast Cancer Female, Acute Leukemia, Lymphoma
- What is being tested?
- Triptorelin Embonate and Sodium Chloride solution 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 17 sitesSweden
- Study dates
- 31 Mar 2023to 31 Jan 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 42 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent
- Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy
- Confirmed menarche
- ECOG performance status 0-1
- Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders
Who cannot join
- 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
Show all 10Show fewer
- Known low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias
- Known or suspected allergy against triptorelin
- Direct radiation of the gonads previous or planned (TBI allowed)
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hanna Nilsson, PhD contact
17 sites in 1 country
Sweden17 sites, 16 recruiting
- Not yet recruiting
Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth
Gothenburg
Karin Mellgren
- Not yet recruiting
Center for Pediatric Oncology, Akademiska Hospital
Gothenburg
Per Frisk
- Not yet recruiting
Department of Oncology, Sahlgrenska University Hospital
Gothenburg
Barbro Linderholm
- Not yet recruiting
Department of Hematology, Skåne University Hospital
Lund
Niklas Loman
- Not yet recruiting
Department of Oncology, Skåne University Hospital
Lund
Mats Jerkerman
- Not yet recruiting
Department of Pediatric Oncology, Skåne University Hospital
Lund
Helena Mörse
- Active, not recruiting
Department of Oncology, Örebro University Hospital
Örebro
- Recruiting
Karolinska Univeristy Hospital, Breast Centre
Stockholm, 17176
Theo Foukakis, MD, PhD, theo.foukakis@ki.se
- Not yet recruiting
Department of Hematology and coagulation, Sahlgrenska University Hospital
Stockholm
Lovisa Vennström
- Not yet recruiting
Department of Hematology, Capio ST. Göran Hospital
Stockholm
Barbro Kedinge
- Not yet recruiting
Department of Internal Medicine, Södersjukhuset
Stockholm
Annelie Liljegren
- Not yet recruiting
Department of Oncology, Capio ST. Göran Hospital
Stockholm
Erika Isaksson Friman
- Not yet recruiting
Department of Oncology, Södersjukhuset
Stockholm
Christina Linder-Stragliotto
- Recruiting
Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet
Stockholm
Per Ljungman
- Recruiting
Karolinska University Hospital, Hematology
Stockholm
Sara Harrysson, MD, PhD, sara.harrysson@regionstockholm.se
- Recruiting
Karolinska University Hospital, High Specialised Pediatric Medicine
Stockholm
Johan Malmros, MD, PhD, johan.malmros@ki.se
- Not yet recruiting
Department of Oncology, Norrlands University Hospital
Umeå
Anne Andersson
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Breast Cancer Female, Acute Leukemia, Lymphoma, Osteosarcoma, Soft Tissue Sarcoma, Ewing Sarcoma
- Being tested
- Triptorelin Embonate, Sodium Chloride solution 0.9%
- Keywords
- Fertility protection of young women receiving chemotherapy
- Medical subject headings
- Lymphoma, Osteosarcoma, Sarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin EmbonateDrug
Also called Pamorelin
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.
Sodium Chloride solution 0.9%Drug
Also called Placebo
One injection compensating for 3 months' effect OR one injection compensating for 1 month' effect to maintain the study blind.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Triptorelin | Experimental | Triptorelin given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment.
The dose is ether 11.25 mg triptorelin given for subjects having at least 3 months gonadotoxic treatment, OR 3.75 mg for subjects during one-month of gonadotoxic treatment Receives: Drug: Triptorelin Embonate |
| Arm B: Placebo | Placebo comparator | Placebo, 0.9% sodium chloride, given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment.
The dose will be provided both as one injection compensating for 3 months' effect and one injection compensating for 1 month' effect to maintain the study blind. Receives: Drug: Sodium Chloride solution 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Müllerian Hormone (AMH) levels in women with breast cancer
To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH relative to AMH levels at EoT in women with breast cancer.
Measured: 12 months after end of gonadotoxic chemotherapy and study drug treatment
Secondary outcomes (19)
Anti-Müllerian Hormone (AMH) levels in women with acute leukemias, lymphomas and sarcomas.
To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH relative to AMH levels at EoT in women with acute leukemias, lymphomas and sarcomas.
Measured: 12 months after end of gonadotoxic chemotherapy and study drug treatment
Changes in ovarian reserve with or without Gonadotropin-Releasing Hormone agonist (GnRHa) by determination of the antral follicle counts (AFC)
Changes in AFC in women with breast cancer and with acute leukemia, lymphoma and sarcoma respectively
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months) and at 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT
Changes in ovarian reserve with or without GnRHa by longitudinal observation of AMH levels
The difference in recovery of AMH levels between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively
Measured: At 6 months, 2 years, 3 years, 4 years and 5 years after EoT.
The proportion of females with or without GnRHa that develop ovarian insufficiency by determination of follicle stimulating hormone (FSH), inhibin and estradiol
Comparison of FSH, inhibin and estradiol between the GnRHa group and the placebo group
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of body mass index (BMI) (Kg/m2) on changes in ovarian reserve with or without GnRHa
longitudinal observation of AMH levels, FSH, inhibin and estradiol
Measured: At Baseline, during treatment, at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of use of contraceptives (yes/no) in changes of ovarian reserve with or without GnRHa
longitudinal observation of AMH levels, FSH, inhibin and estradiol
Measured: At Baseline, during treatment visits (every 1-3 months of gonadotoxic treatment), at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of endocrine adjuvant therapy (yes/no) in changes of ovarian reserve with or without GnRHa
longitudinal observation of AMH levels, FSH, inhibin and estradiol
Measured: At Baseline, during treatment visits (every 1-3 months of gonadotoxic treatment), at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The effect of GnRHa with or without GnRHa on ovarian blood supply
Comparison of blood flow to the ovarian artery (right and left Doppler flow) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The proportion of females with or without GnRHa that develop amenorrhea (no menstruations)
Comparison of the proportion that develop amenorrhea (no menstruations) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Pregnacy wish after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Comparison of of pregnancy wish (Study specific questionaire) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Comparison of pregnancy attempts (Study specific questionaire) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At end of chemotherapy (corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Comparison of pregnancy outcome between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (EORTC QLQ C30)
Comparison of validated outcome on health-related QoL (EORTC QLQ C30) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (FSFI)
Comparison of validated outcome of sexuality and reproductive health (Female Sexual Function Index (FSFI)) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (HAD)
Comparison of validated outcome on health-related QoL (Hospital Anxiety and Depression Scale (HAD)) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The development of co-morbidities during follow-up and bone mineral density
Comparison of bone mineral density between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At baseline, at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months) and 12 months and 5 years after EoT
Disease-specific oncologic outcomes: disease-free survival
Investigation of disease-free survival between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Disease-specific oncologic outcomes: Recurrence rate
Investigation of recurrence rate between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Disease-specific oncologic outcomes: overall survival
Investigation of overall survival between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.
Measured: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start31 Mar 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, double-blinded, placebo-controlled, phase 3 study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenny Rodriguez-Wallberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenny Rodriguez-Wallberg, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328258
- Sponsor's protocol ID
- ProFertil
- Acronym
- ProFertil
- Status last verified
- Oct 2023
- First submitted
- 29 Mar 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The identity of the individual participants is protected by GDPR through the The Swedish Authority for Privacy Protection as regulated by the informed consent and any data sharing must be in accordance with their regulations. We can thus only share IPD that underlie the results reported in this study (text, tables, figures, and appendices), after full anonymization of the data. After completion of the study the protocol, informed consent form and statistical analysis plan will be available. Requests for additional analyses or to access the anonymized datasets should be directed to kenny.rodriguez-wallberg@ki.se. Information will be available upon reasonable request to the sponsor and if in correspondence with the proposed research in the signed informed consent e.g to achieve aims in the approved proposal.
Publications
Rodriguez-Wallberg KA, Nilsson HP, Bergh J, Malmros J, Ljungman P, Foukakis T, Stragliotto CL, Friman EI, Linderholm B, Valachis A, Andersson A, Harrysson S, Vennstrom L, Frisk P, Morse H, Eloranta S. ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden-a phase III randomised double-blinded placebo-controlled study. BMJ Open. 2023 Dec 9;13(12):e078023. doi: 10.1136/bmjopen-2023-078023.
PubMed 38070906
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05328258
- Acronym / sponsor ID
- ProFertil / ProFertil
- Conditions
- Breast Cancer Female, Acute Leukemia, Lymphoma, Osteosarcoma, Soft Tissue Sarcoma, Ewing Sarcoma
- Keywords
- Fertility protection of young women receiving chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kenny Rodriguez-WallbergUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomised, double-blinded, placebo-controlled, phase 3 study
| Arm | Type | Receives |
|---|---|---|
| Arm A: Triptorelin | Experimental | Drug: Triptorelin EmbonateTriptorelin given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment. The dose is ether 11.25 mg triptorelin given for subjects having at least 3 months gonadotoxic treatment, OR 3.75 mg for subjects during one-month of gonadotoxic treatment |
| Arm B: Placebo | Placebo comparator | Drug: Sodium Chloride solution 0.9%Placebo, 0.9% sodium chloride, given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment. The dose will be provided both as one injection compensating for 3 months' effect and one injection compensating for 1 month' effect to maintain the study blind. |
Who may qualify
- Ages
- 14 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy
- Confirmed menarche
- ECOG performance status 0-1
- Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin EmbonateAlso: Pamorelin11.25 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. | Drug | Arm A: Triptorelin |
| Sodium Chloride solution 0.9%Also: PlaceboOne injection compensating for 3 months' effect OR one injection compensating for 1 month' effect to maintain the study blind. | Drug | Arm B: Placebo |
Primary outcome
Anti-Müllerian Hormone (AMH) levels in women with breast cancer
Time frame: 12 months after end of gonadotoxic chemotherapy and study drug treatment
To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH relative to AMH levels at EoT in women with breast cancer.
19 secondary outcomes
Anti-Müllerian Hormone (AMH) levels in women with acute leukemias, lymphomas and sarcomas.
Time frame: 12 months after end of gonadotoxic chemotherapy and study drug treatment
Changes in ovarian reserve with or without Gonadotropin-Releasing Hormone agonist (GnRHa) by determination of the antral follicle counts (AFC)
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months) and at 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT
Changes in ovarian reserve with or without GnRHa by longitudinal observation of AMH levels
Time frame: At 6 months, 2 years, 3 years, 4 years and 5 years after EoT.
The proportion of females with or without GnRHa that develop ovarian insufficiency by determination of follicle stimulating hormone (FSH), inhibin and estradiol
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of body mass index (BMI) (Kg/m2) on changes in ovarian reserve with or without GnRHa
Time frame: At Baseline, during treatment, at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of use of contraceptives (yes/no) in changes of ovarian reserve with or without GnRHa
Time frame: At Baseline, during treatment visits (every 1-3 months of gonadotoxic treatment), at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Impact of endocrine adjuvant therapy (yes/no) in changes of ovarian reserve with or without GnRHa
Time frame: At Baseline, during treatment visits (every 1-3 months of gonadotoxic treatment), at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The effect of GnRHa with or without GnRHa on ovarian blood supply
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The proportion of females with or without GnRHa that develop amenorrhea (no menstruations)
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Pregnacy wish after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Time frame: At end of chemotherapy (corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (EORTC QLQ C30)
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (FSFI)
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Health-related quality of life (HAD)
Time frame: At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
The development of co-morbidities during follow-up and bone mineral density
Time frame: At baseline, at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months) and 12 months and 5 years after EoT
Disease-specific oncologic outcomes: disease-free survival
Time frame: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Disease-specific oncologic outcomes: Recurrence rate
Time frame: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Disease-specific oncologic outcomes: overall survival
Time frame: At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Derived from this study: PubMed 38070906Rodriguez-Wallberg KA, Nilsson HP, Bergh J, Malmros J, Ljungman P, Foukakis T, Stragliotto CL, Friman EI, Linderholm B, Valachis A, Andersson A, Harrysson S, Vennstrom L, Frisk P, Morse H, Eloranta S. ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden-a phase III randomised double-blinded placebo-controlled study. BMJ Open. 2023 Dec 9;13(12):e078023. doi: 10.1136/bmjopen-2023-078023.
- Individual participant dataSharing planned: No. The identity of the individual participants is protected by GDPR through the The Swedish Authority for Privacy Protection as regulated by the informed consent and any data sharing must be in accordance with their regulations. We can thus only share IPD that underlie the results reported in this study (text, tables, figures, and appendices), after full anonymization of the data. After completion of the study the protocol, informed consent form and statistical analysis plan will be available. Requests for additional analyses or to access the anonymized datasets should be directed to kenny.rodriguez-wallberg@ki.se. Information will be available upon reasonable request to the sponsor and if in correspondence with the proposed research in the signed informed consent e.g to achieve aims in the approved proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Nilsson, PhD contact
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptorelin Embonate and Sodium Chloride solution 0.9% in people with Breast Cancer Female and Acute Leukemia, run by Kenny Rodriguez-Wallberg at 17 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenny Rodriguez Wallberg, MD, PhD (+46 858580000, kenny.rodriguez-wallberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Müllerian Hormone (AMH) levels in women with breast cancer (time frame: 12 months after end of gonadotoxic chemotherapy and study drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05328258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.