PREgnancy and FERtility Registry

Study Overview
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Brief Summary
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The PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize care and improve knowledge around the topics of fertility preservation and pregnancy issues in young breast cancer patients. The program was initiated at the National Institute for Cancer Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it has been spread to other Italian Institutions under the umbrella of the Gruppo Italiano Mammella (GIM) study group. It is composed of two distinctive studies, one assessing fertility (i.e. PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence, two different study protocols were developed under the umbrella of the PREFER registry. PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of young cancer patients on the fertility preservation strategies available in Italy. Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies for fertility preservation in terms of success of the techniques (i.e. recovery of ovarian function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e. long-term survival outcomes). PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments, and the long-term survival outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of breast cancer.

Official Title
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An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)

Conditions
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Breast Neoplasms, Pregnancy, Fertility Preservation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breast cancer diagnosis age between18 and 45 years (only for PREFER-FERTILITY) have not received any radiation or chemotherapy for cancer before enrolment (only for PREFER-FERTILITY) absence of metastatic disease (only for PREFER-FERTILITY) diagnosis of breast cancer during pregnancy or within 1 year from the end of pregnancy or pregnancy after prior diagnosis and treatment for breast cancer (only for PREFER-PREGNANCY) informed consent Exclusion Criteria: inability to provide written informed consent stage IV disease at diagnosis (only for PREFER-FERTILITY) serious psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients interested in the available strategies for fertility preservation | Assessed through medical records | 15 years | 
| Rate of patients undergoing the different strategies for fertility preservation | Assessed through medical records | 15 years | 
| Type of strategies for fertility preservation proposed by oncologists | Assessed through medical records | 15 years | 
| Reasons for refusal of the available strategies for fertility preservation | Assessed through an open questionnaire | 15 years | 
| Type of anticancer therapies administered during pregnancy | Assessed through medical records | 15 years | 
| Safety: pregnancy complications | Assessed through medical records | 15 years | 
| Safety: incidence of adverse events | Assessed through medical records | 15 years | 
| Disease-free survival |  | 15 years | 
| Overall survival |  | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments |  | 15 years | 
| Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved |  | 15 years | 
| Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments |  | 15 years | 
| Serum hormonal changes during chemotherapy and study follow up | FSH (follicle stimulating hormone), estradiol and AMH (anti-mullerian hormone) serum levels assessed at baseline, during chemotherapy, at the end of chemotherapy and every six months thereafter | 15 years | 
| Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments | Assessed using obstetric and paediatric medical records | 15 years | 
| Obstetrical and paediatric care of children born in breast cancer survivors | Assessed using obstetric and paediatric medical records | 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast neoplasms, fertility preservation, pregnancy