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Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE) (fAMHOPE)

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ClinicalTrials.gov Identifier: NCT04289805
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : August 4, 2022
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
Erasme University Hospital

Brief 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 women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Malignant Female Drug: Letrozole Other: standard-stimulated cohort Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 565 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : January 30, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Arm Intervention/treatment
Active Comparator: standard-stimulated cohort
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.
Other: standard-stimulated cohort

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.

Other Name: COS

Experimental: letrozole-stimulated cohort
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.
Drug: Letrozole

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.

Other Name: Controlled Ovarian Stimulation (COS)

No Intervention: non-stimulated cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of patient with adverse events due to COS: OHSS [ Time Frame: Through treatment procedure, an average of 2 weeks after inclusion ]
    Adverse events reporting during COS (Ovarian Hyperstimulation syndrome-OHSS)

  2. Characteristics of Ovarian stimulation: total gonadotropin doses [ Time Frame: An average of 2 weeks after inclusion ]
    Total gonadotropin doses (International Unit- IU)

  3. Characteristics of Ovarian stimulation: duration of the COS [ Time Frame: An average of 2 weeks after inclusion ]
    duration of the COS (days)

  4. Characteristics of Ovarian stimulation: type of stimulation [ Time Frame: An average of 2 weeks after inclusion ]
    type of stimulation (standard or random-start).

  5. Efficacy of the ovarian stimulation and oocyte collection: Maturation rate [ Time Frame: An average of 2 weeks after inclusion ]
    Maturation rate (number of total oocyte collected/number of mature oocytes)

  6. Outcomes of assisted reproductive technology procedures [ Time Frame: Through study completion, 5 years ]
    Number of pregnancies and outcomes (premature delivery, miscarriage, abortion, delivery healthy babies, congenital malformation).

  7. Anticancer therapies effect on ovarian function: progesterone [ Time Frame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months ]
    Hormonal measurements Progesterone ng/ml

  8. Anticancer therapies effect on ovarian function: AMH [ Time Frame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months ]
    Anti-Mullerian Hormone (AMH) measurements AMH ng/ml

  9. Anticancer therapies effect on ovarian function: FSH [ Time Frame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months ]
    Follicle-Stimulating Hormone (FSH) measurements FSH IU/L

  10. Anticancer therapies effect on ovarian function: E2 [ Time Frame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months ]
    Hormonal measurements E2 pg/ml

  11. Anticancer therapies effect on ovarian function [ Time Frame: An average 18 months, 30 months, 60 months after inclusion ]
    Amenorrhea rate (6months without spontaneous menstruation)

  12. Oncological outcomes 1 [ Time Frame: 5 years ]
    Invasive disease-free survival (iDFS)

  13. Oncological outcomes 2 [ Time Frame: 5 years ]
    breast cancer-free interval (BCFI)

  14. Oncological outcomes 3 [ Time Frame: 5 years ]
    overall survival (OS)

  15. Circulating breast cancer cells level before stimulation [ Time Frame: Inclusion ]
    circulating tumor DNA (ctDNA)

  16. Circulating breast cancer cells level after stimulation [ Time Frame: average of 2weeks after inclusion ]
    circulating tumor DNA (ctDNA)

  17. Number of patient with adverse events due to egg collection [ Time Frame: An average of 2 weeks after inclusion ]
    bleeding

  18. Number of patient with adverse events due to egg collection [ Time Frame: An average of 2 weeks after inclusion ]
    pelvic infection

  19. Efficacy of the in vitro fertilization procedure: Fertilization rate [ Time Frame: Through study completion, 5 years ]
    Fertilization rate (number of oocyte fertilized/number of embryo obtained)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer);
  • Prior diagnosis of other malignancies before breast cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289805


Contacts
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Contact: Isabelle Demeestere, MD,PhD 003225556592 isabelle.demeestere@ulb.be
Contact: Julie Dechene 003225556779 julie.dechene@ulb.be

Locations
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Belgium
CUB-Hôpital Erasme Recruiting
Brussel, Belgium, 1070
Contact: Julie Dechène    00 32 2 555 67 79    julie.dechene@ulb.be   
Contact: Lydia Ait Ahcene    0032 2 555 69 26    lydia.ait.ahcene@erasme.ulb.ac.be   
Principal Investigator: Oranite Goldrat, Md, PhD         
CHIREC- Hospital Delta Not yet recruiting
Brussel, Belgium, 1160
Contact: Romain Imbert, MD         
Principal Investigator: Romain Imbert, MD         
CHC-Saint Vincent Recruiting
Liège, Belgium, 4000
Contact: Chantal Schugens    0032 4 355 42 73    chantal.schugens@chc.be   
Contact: Carine Garnier    0032 4 355 42 50    carine.garnier@chc.be   
Principal Investigator: Annick Delvigne, MD, PhD         
France
Centre Oscar Lambret Recruiting
Lille, France, 59000
Contact: Aline BARBERIO    0033 3 20 29 56 15    a-barberio@o-lambret.fr   
Sub-Investigator: audrey Mailliez, MD         
CHRU Lille Recruiting
Lille, France, 59037
Contact: Christine Decanter, MD         
Principal Investigator: Christine Decanter, MD         
Italy
Ospedale San Martino Not yet recruiting
Genova, Italy, 16132
Contact: Matteo Lambertini, MD, PhD         
Principal Investigator: Matteo Lambertini, MD, PhD         
Sponsors and Collaborators
Erasme University Hospital
University Hospital, Lille
Investigators
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Study Director: Isabelle Demeestere, MD, PhD CUB-Hôpital Erasme
Study Chair: Matteo Lambertini, MD, PhD ULB
Study Chair: Christine Decanter, MD CHRU Lille
  Study Documents (Full-Text)

Documents provided by Erasme University Hospital:
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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT04289805    
Other Study ID Numbers: SRB_201808_163
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erasme University Hospital:
Fertility preservation
Letrozole
Ovarian stimulation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs