Breast Neoplasms Clinical Trial
— BrovaleOfficial title:
Efficiency and Safety Study of Ovarian Stimulation With Letrozole for Fertility Preservation in Breast Cancer Patients
Verified date | August 2022 |
Source | Erasme University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate efficiency and safety of controlled ovarian stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility preservation in breast cancer patients.
Status | Active, not recruiting |
Enrollment | 65 |
Est. completion date | September 2023 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Breast cancer female patients of less than 41 years old - Addressed to fertility preservation Unit before starting chemotherapy Exclusion Criteria: - Metastatic breast cancer - Known premature ovarian failure - Basal FSH > 20 IU(International Unit) - Surgical contra-indications |
Country | Name | City | State |
---|---|---|---|
Belgium | Erasme-CUB | Brussels |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital |
Belgium,
Azim AA, Costantini-Ferrando M, Oktay K. Safety of fertility preservation by ovarian stimulation with letrozole and gonadotropins in patients with breast cancer: a prospective controlled study. J Clin Oncol. 2008 Jun 1;26(16):2630-5. doi: 10.1200/JCO.2007.14.8700. — View Citation
Goldrat O, Gervy C, Englert Y, Delbaere A, Demeestere I. Progesterone levels in letrozole associated controlled ovarian stimulation for fertility preservation in breast cancer patients. Hum Reprod. 2015 Sep;30(9):2184-9. doi: 10.1093/humrep/dev155. Epub 2 — View Citation
Oktay K, Hourvitz A, Sahin G, Oktem O, Safro B, Cil A, Bang H. Letrozole reduces estrogen and gonadotropin exposure in women with breast cancer undergoing ovarian stimulation before chemotherapy. J Clin Endocrinol Metab. 2006 Oct;91(10):3885-90. Epub 2006 Aug 1. — View Citation
Oktay K, Turan V, Bedoschi G, Pacheco FS, Moy F. Fertility Preservation Success Subsequent to Concurrent Aromatase Inhibitor Treatment and Ovarian Stimulation in Women With Breast Cancer. J Clin Oncol. 2015 Aug 1;33(22):2424-9. doi: 10.1200/JCO.2014.59.3723. Epub 2015 Jun 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oocyte maturation rate | Following letrozole associated COS, oocytes are collected and evaluated for maturation rate (%).
These results are prospectively compared to infertile patients undergoing similar COS (GnRH antagonist protocol) without letrozole. |
At oocyte collection (48 hours after last administration of letrozole, following COS protocol). | |
Secondary | Hormonal levels | Estradiol and Progesterone levels are measured on serum samples to confirm the effect of COS associated with letrozole on hormonal levels | during stimulation at ovulation trigger and oocyte retrieval and during luteal phase (days 3 and 8) | |
Secondary | Circulating tumoral DNA | 3 EDTA (Ethylene Diamine Tetra-Acetic Acid) tubes are collected for plasma extraction. 1 EDTA tube is collected for whole blood.
Circulating tumoral DNA will be assessed on plasma samples according to primary tumoral mutation screening. Whole blood will used as reference. |
At enrollment (before letrozole associated COS) and at oocyte retrieval (48 hours after last administration of letrozole, following COS protocol) | |
Secondary | Comparison of breast cancer recurrence rate in patients who underwent letrozole associated COS with an oncological control group | Oncological follow-up for relapse risk assessment will be carried out at 2 and 5 years of follow-up by medical chart review. Local, contralateral and/or distant recurrence of the disease will be reported.
These data will be compared to a control group matched for age and type of disease who were diagnosed with breast cancer during the same period but did not undergo letrozole associated COS for fertility preservation. |
2 and 5 years after letrozole associated COS | |
Secondary | Ovarian reserve | AMH (anti-mullerian hormone) and FSH (follicle stimulating hormone) are assessed on blood samples to evaluate the gonadotoxicity of chemotherapy. | At enrollment, 2 and 5 years after letrozole associated COS for fertility preservation | |
Secondary | Obstetrical outcome: malformation rate | Malformation will be evaluated in patients who conceive with a previously vitrified oocyte (following letrozole associated COS): malformation assessment during prenatal morphology ultrasound and/or at birth | Through study completion: data collection at 2 and 5 years after letrozole associated COS | |
Secondary | Neonatal outcomes: gestational age at birth | Neonatal outcomes will be evaluated in patients who conceive with a previously vitrified oocyte (following letrozole associated COS): gestational age at birth. Preterm delivery is defined by birth < 37 weeks gestation. | Through study completion: data collection at 2 and 5 years after letrozole associated COS | |
Secondary | Neonatal outcomes: delivery procedure | Neonatal outcomes will be evaluated in patients who conceive with a previously vitrified oocyte (following letrozole associated COS). Delivery procedure is defined as spontaneous, instrumental or cesarean section | Through study completion: data collection at 2 and 5 years after letrozole associated COS | |
Secondary | Neonatal outcomes: birth weight | Neonatal outcomes will be evaluated in patients who conceive with a previously vitrified oocyte (following letrozole associated COS). Birth weight will be reported in grams. | Through study completion: data collection at 2 and 5 years after letrozole associated COS |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT03664778 -
Abbreviated Breast MRI After Cancer Treatment
|
||
Recruiting |
NCT03144622 -
18F-FSPG PET/CT Imaging in Patients With Cancers
|
||
Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
Active, not recruiting |
NCT04568902 -
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT02860585 -
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03698942 -
Delphinus SoftVueâ„¢ ROC Reader Study
|
||
Completed |
NCT00092950 -
Exercise in Women at Risk for Breast Cancer
|
Phase 2 | |
Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02151071 -
The Breast Surgery EnLight and LightPath Imaging System Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT02934360 -
TR(ACE) Assay Clinical Specimen Study
|
N/A | |
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A | |
Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
N/A |