PREgnancy and FERtility Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Pregnancy, Fertility Preservation. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)
Overview
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.
Primary outcome measures
- Rate of patients interested in the available strategies for fertility preservation [Time frame: 15 years]
- Rate of patients undergoing the different strategies for fertility preservation [Time frame: 15 years]
- Type of strategies for fertility preservation proposed by oncologists [Time frame: 15 years]
- Reasons for refusal of the available strategies for fertility preservation [Time frame: 15 years]
- Type of anticancer therapies administered during pregnancy [Time frame: 15 years]
- Safety: pregnancy complications [Time frame: 15 years]
- Safety: incidence of adverse events [Time frame: 15 years]
- Disease-free survival [Time frame: 15 years]
- Overall survival [Time frame: 15 years]
Secondary outcome measures (6)
- Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments [Time frame: 15 years]
- Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved [Time frame: 15 years]
- Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments [Time frame: 15 years]
- Serum hormonal changes during chemotherapy and study follow up [Time frame: 15 years]
- Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments [Time frame: 15 years]
- Obstetrical and paediatric care of children born in breast cancer survivors [Time frame: 15 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 23 centers
- Ospedale Cardinal Massaia — Asti
- Presidio Ospedaliero 'Antonio Perrino' — Brindisi
- AOU di Cagliari Strada — Monserrato
- Azienda Ospedaliera S. Croce e Carle — Cuneo
- Arcispedale S. Anna - A.O.U. di Ferrara — Cona
- Irccs Aou San Martino - Ist — Genoa
- Ospedale Vito Fazzi — Lecce
- Ospedale Unico Versilia — Lido di Camaiore
- … and 15 more centers
Publications
- Lambertini M, Anserini P, Fontana V, Poggio F, Iacono G, Abate A, Levaggi A, Miglietta L, Bighin C, Giraudi S, D'Alonzo A, Blondeaux E, Buffi D, Campone F, Merlo DF, Del Mastro L. The PREgnancy and FERtility (PREFER) study: an Italian multicenter prospective cohort study on fertility preservation and pregnancy issues in young breast cancer patients. BMC Cancer. 2017 May 19;17(1):346. doi: 10.1186/ PMID 28526012
Identifiers
NCT: NCT02895165 · 001377;000650