Breast Neoplasm Malignant FemalePhase 4fAMHOPENCT04289805
Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
A Phase 4 study testing Letrozole and standard-stimulated cohort in people with Breast Neoplasm Malignant Female, run by Erasme University Hospital at 6 sites in 3 countries.
Trial summary
This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Neoplasm Malignant Female
- What is being tested?
- Letrozole and standard-stimulated cohort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 25 Feb 2019to 15 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of invasive non-metastatic breast cancer (i.e. stage I to III);
- Breast cancer diagnosis ≥18 and ≤ 40 years;
- No prior history of gonadotoxic treatments;
- Fertility preservation counseling for fertility preservation;
- Written inform consent;
- FSH < 20 UI/L and/or antra-follicular count ≥ 6 (follicles of 2-9 mm) and/or AMH ≥ 6 pmol (only applicable for patients who undergo controlled ovarian stimulation for embryo/oocyte cryopreservation).
Who cannot join
- Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer);
- Prior diagnosis of other malignancies before breast cancer.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Belgium3 sites
CUB-Hôpital Erasme
Brussels, 1070
CHIREC- Hospital Delta
Brussels, 1160
CHC-Saint Vincent
Liège, 4000
About this study
Official title: A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.
Read the detailed description
Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a Gonadotropin Releasing Hormone-GnRH agonist.
After retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification.
Primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.
- Conditions
- Breast Neoplasm Malignant Female
- Being tested
- Letrozole, standard-stimulated cohort
- Keywords
- Fertility preservation, Letrozole, Ovarian stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Controlled Ovarian Stimulation (COS)
Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol.
"Standard Protocol": letrozole is orally administered (5mg/d) from cycle day 2-3 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering.
"Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins.
GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm.
Oocytes are collected 36h after ovulation triggering with GnRH agonist.
standard-stimulated cohortOther
Also called COS
Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol.
"Standard Protocol": Gonadotrophins started from cycle day 2-3 throughout the ovarian stimulation until ovulation triggering.
"Random start" protocol: Gonadotrophins started at any time of the cycle and throughout the stimulation.
GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm.
Oocytes are collected 36h after ovulation triggering with GnRH agonist.
| Study group | Role | What they receive |
|---|---|---|
| standard-stimulated cohort | Active comparator | this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the French participating centres. Receives: Other: standard-stimulated cohort |
| letrozole-stimulated cohort | Experimental | this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the Belgian participating centres. Receives: Drug: Letrozole |
| non-stimulated cohort | No intervention | this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and who have access to the Fertility Clinics in all the participating centres but are not willing to preserve their fertility by undergoing oocyte/embryo cryopreservation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected
Number of mature oocytes collected
Measured: an average of 2 weeks after inclusion
Secondary outcomes (19)
Number of patient with adverse events due to COS: OHSS
Adverse events reporting during COS (Ovarian Hyperstimulation syndrome-OHSS)
Measured: Through treatment procedure, an average of 2 weeks after inclusion
Characteristics of Ovarian stimulation: total gonadotropin doses
Total gonadotropin doses (International Unit- IU)
Measured: An average of 2 weeks after inclusion
Characteristics of Ovarian stimulation: duration of the COS
duration of the COS (days)
Measured: An average of 2 weeks after inclusion
Characteristics of Ovarian stimulation: type of stimulation
type of stimulation (standard or random-start).
Measured: An average of 2 weeks after inclusion
Efficacy of the ovarian stimulation and oocyte collection: Maturation rate
Maturation rate (number of total oocyte collected/number of mature oocytes)
Measured: An average of 2 weeks after inclusion
Outcomes of assisted reproductive technology procedures
Number of pregnancies and outcomes (premature delivery, miscarriage, abortion, delivery healthy babies, congenital malformation).
Measured: Through study completion, 5 years
Anticancer therapies effect on ovarian function: progesterone
Hormonal measurements Progesterone ng/ml
Measured: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
Anticancer therapies effect on ovarian function: AMH
Anti-Mullerian Hormone (AMH) measurements AMH ng/ml
Measured: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
Anticancer therapies effect on ovarian function: FSH
Follicle-Stimulating Hormone (FSH) measurements FSH IU/L
Measured: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
Anticancer therapies effect on ovarian function: E2
Hormonal measurements E2 pg/ml
Measured: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
Anticancer therapies effect on ovarian function
Amenorrhea rate (6months without spontaneous menstruation)
Measured: An average 18 months, 30 months, 60 months after inclusion
Oncological outcomes 1
Invasive disease-free survival (iDFS)
Measured: 5 years
Oncological outcomes 2
breast cancer-free interval (BCFI)
Measured: 5 years
Oncological outcomes 3
overall survival (OS)
Measured: 5 years
Circulating breast cancer cells level before stimulation
circulating tumor DNA (ctDNA)
Measured: Inclusion
Circulating breast cancer cells level after stimulation
circulating tumor DNA (ctDNA)
Measured: average of 2weeks after inclusion
Number of patient with adverse events due to egg collection
bleeding
Measured: An average of 2 weeks after inclusion
Number of patient with adverse events due to egg collection
pelvic infection
Measured: An average of 2 weeks after inclusion
Efficacy of the in vitro fertilization procedure: Fertilization rate
Fertilization rate (number of oocyte fertilized/number of embryo obtained)
Measured: Through study completion, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start25 Feb 2019
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Why it stopped: The study had to be terminated due to the new European legislation on drug studies. This legislation requires all studies aimed at evaluating treatments to be registered as such, even in the context of Standard of Care.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm Malignant 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups: * 113 patients in the standard-stimulated cohort, * 113 patients in the letrozole-stimulated cohort, * 339 patients in the non-stimulated cohort.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Isabelle Demeestere, MD, PhD, Study director, CUB-Hôpital ErasmeMatteo Lambertini, MD, PhD, Study chair, ULBChristine Decanter, MD, Study chair, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289805
- Sponsor's protocol ID
- SRB_201808_163
- Acronym
- fAMHOPE
- Status last verified
- Dec 2024
- First submitted
- 17 Jul 2019
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
- ClinicalTrials.gov ID
- NCT04289805
- Acronym / sponsor ID
- fAMHOPE / SRB_201808_163
- Conditions
- Breast Neoplasm Malignant Female
- Keywords
- Fertility preservation, Letrozole, Ovarian stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study had to be terminated due to the new European legislation on drug studies. This legislation requires all studies aimed at evaluating treatments to be registered as such, even in the context of Standard of Care.
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 28 Feb 2020 (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.
This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.
Detailed description
Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a Gonadotropin Releasing Hormone-GnRH agonist.
After retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification.
Primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups: * 113 patients in the standard-stimulated cohort, * 113 patients in the letrozole-stimulated cohort, * 339 patients in the non-stimulated cohort.
| Arm | Type | Receives |
|---|---|---|
| standard-stimulated cohort | Active comparator | Other: standard-stimulated cohortthis cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the French participating centres. |
| letrozole-stimulated cohort | Experimental | Drug: Letrozolethis cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the Belgian participating centres. |
| non-stimulated cohort | No intervention | –this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and who have access to the Fertility Clinics in all the participating centres but are not willing to preserve their fertility by undergoing oocyte/embryo cryopreservation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of invasive non-metastatic breast cancer (i.e. stage I to III);
- Breast cancer diagnosis ≥18 and ≤ 40 years;
- No prior history of gonadotoxic treatments;
- Fertility preservation counseling for fertility preservation;
- Written inform consent;
Key exclusion criteria (2 listed)
- Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer);
- Prior diagnosis of other malignancies before breast cancer.
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 |
|---|---|---|
| LetrozoleAlso: Controlled Ovarian Stimulation (COS)Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol. "Standard Protocol": letrozole is orally administered (5mg/d) from cycle day 2-3 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering. "Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins. GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm. Oocytes are collected 36h after ovulation triggering with GnRH agonist. | Drug | letrozole-stimulated cohort |
| standard-stimulated cohortAlso: COSPatients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol. "Standard Protocol": Gonadotrophins started from cycle day 2-3 throughout the ovarian stimulation until ovulation triggering. "Random start" protocol: Gonadotrophins started at any time of the cycle and throughout the stimulation. GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm. Oocytes are collected 36h after ovulation triggering with GnRH agonist. | Other | standard-stimulated cohort |
Primary outcome
Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected
Time frame: an average of 2 weeks after inclusion
Number of mature oocytes collected
19 secondary outcomes
Number of patient with adverse events due to COS: OHSS
Time frame: Through treatment procedure, an average of 2 weeks after inclusion
Characteristics of Ovarian stimulation: total gonadotropin doses
Time frame: An average of 2 weeks after inclusion
Characteristics of Ovarian stimulation: duration of the COS
Time frame: An average of 2 weeks after inclusion
Characteristics of Ovarian stimulation: type of stimulation
Time frame: An average of 2 weeks after inclusion
Efficacy of the ovarian stimulation and oocyte collection: Maturation rate
Time frame: An average of 2 weeks after inclusion
Outcomes of assisted reproductive technology procedures
Time frame: Through study completion, 5 years
Anticancer therapies effect on ovarian function: progesterone
Time frame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
Anticancer therapies effect on ovarian function: AMH
Time frame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
Anticancer therapies effect on ovarian function: FSH
Time frame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
Anticancer therapies effect on ovarian function: E2
Time frame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
Anticancer therapies effect on ovarian function
Time frame: An average 18 months, 30 months, 60 months after inclusion
Oncological outcomes 1
Time frame: 5 years
Oncological outcomes 2
Time frame: 5 years
Oncological outcomes 3
Time frame: 5 years
Circulating breast cancer cells level before stimulation
Time frame: Inclusion
Circulating breast cancer cells level after stimulation
Time frame: average of 2weeks after inclusion
Number of patient with adverse events due to egg collection
Time frame: An average of 2 weeks after inclusion
Number of patient with adverse events due to egg collection
Time frame: An average of 2 weeks after inclusion
Efficacy of the in vitro fertilization procedure: Fertilization rate
Time frame: Through study completion, 5 years
Results and safety
The study was stopped early (reason given: The study had to be terminated due to the new European legislation on drug studies. This legislation requires all studies aimed at evaluating treatments to be registered as such, even in the context of Standard of Care.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Isabelle Demeestere, MD, PhD study director
CUB-Hôpital Erasme
Matteo Lambertini, MD, PhD study chair
ULB
Christine Decanter, MD study chair
CHRU LILLE
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole and standard-stimulated cohort in people with Breast Neoplasm Malignant Female, run by Erasme University Hospital at 6 sites in 3 countries.
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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, France, Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study had to be terminated due to the new European legislation on drug studies. This legislation requires all studies aimed at evaluating treatments to be registered as such, even in the context of Standard of Care.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected (time frame: an average of 2 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2025.