PREgnancy and FERtility Registry
PREFER
An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)
1 other identifier
observational
1,000
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 22, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2032
April 30, 2026
April 1, 2026
15 years
August 22, 2016
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 Outcomes (6)
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
15 years
Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments
15 years
- +1 more secondary outcomes
Eligibility Criteria
Young breast cancer patients facing fertility and pregnancy issues
You may qualify if:
- 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
You may not qualify if:
- inability to provide written informed consent
- stage IV disease at diagnosis (only for PREFER-FERTILITY)
- serious psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Ospedale Cardinal Massaia
Asti, Asti, Italy
Presidio Ospedaliero 'Antonio Perrino'
Brindisi, BR, 72100, Italy
AOU di Cagliari Strada
Monserrato, Cagliari, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, 12100, Italy
Arcispedale S. Anna - A.O.U. di Ferrara
Cona, FE, 44124, Italy
Irccs Aou San Martino - Ist
Genoa, GE, 16132, Italy
Ospedale Vito Fazzi
Lecce, LE, 73100, Italy
Ospedale Unico Versilia
Lido di Camaiore, LU, 55041, Italy
Azienda Ospedaliera Carlo Poma
Mantua, MN, 46100, Italy
Ospedale 'Guglielmo da Saliceto'
Piacenza, PC, 29121, Italy
AOU Pisana - Ospedale S. Chiara
Pisa, Pisa, Italy
Fondazione S. Maugeri IRCCS
Pavia, PV, 27100, Italy
Azienda Ospedaliera S. Carlo
Potenza, PZ, 85100, Italy
Arcispedale Santa Maria Nuova di Reggio Emilia
Reggio Emilia, Reggio Emilia, Italy
Istituto Regina Elena per lo studio e la cura dei tumori
Roma, RM, 00144, Italy
Azienda Ospedaliera n. 1 - Annunziata
Sassari, SS, 07100, Italy
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
Candiolo, TO, 10060, Italy
ASS1 Triestina
Trieste, Trieste, Italy
AOU SM Misericordia
Udine, UD, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, VE, 37024, Italy
A.O.U. Federico II
Naples, 80131, Italy
Istituto Nazionale dei Tumori - Fondazione G.Pascale
Naples, 80131, Italy
Ospedale Santa Maria della Misericordia
Perugia, Italy
Related Publications (1)
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/s12885-017-3348-8.
PMID: 28526012DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 22, 2016
First Posted
September 9, 2016
Study Start
November 1, 2012
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2032
Last Updated
April 30, 2026
Record last verified: 2026-04