PREgnancy and FERtility Registry (PREFER)

April 29, 2026 updated by: Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • A.O.U. Federico II
        • Contact:
        • Principal Investigator:
          • Sabino De Placido, MD
      • Naples, Italy, 80131
        • Recruiting
        • Istituto Nazionale dei Tumori - Fondazione G.Pascale
        • Contact:
        • Principal Investigator:
          • Michelino De Laurentiis, MD
      • Perugia, Italy
        • Recruiting
        • Ospedale Santa Maria della Misericordia
        • Contact:
          • Crinò
    • Asti
      • Asti, Asti, Italy
        • Recruiting
        • Ospedale Cardinal Massaia
        • Contact:
          • Testore
    • BR
      • Brindisi, BR, Italy, 72100
        • Recruiting
        • Presidio Ospedaliero 'Antonio Perrino'
        • Contact:
        • Principal Investigator:
          • Saverio Cinieri, MD
    • CN
      • Cuneo, CN, Italy, 12100
        • Recruiting
        • Azienda Ospedaliera S. Croce e Carle
        • Contact:
        • Principal Investigator:
          • Ornella Garrone, MD
    • Cagliari
      • Monserrato, Cagliari, Italy
        • Active, not recruiting
        • AOU di Cagliari Strada
    • FE
      • Cona, FE, Italy, 44124
        • Recruiting
        • Arcispedale S. Anna - A.O.U. di Ferrara
        • Contact:
        • Principal Investigator:
          • Antonio Frassoldati, MD
    • GE
      • Genoa, GE, Italy, 16132
        • Recruiting
        • IRCCS AOU San Martino - IST
        • Contact:
        • Sub-Investigator:
          • Matteo Lambertini, MD
        • Principal Investigator:
          • Lucia Del Mastro, MD
    • LE
      • Lecce, LE, Italy, 73100
        • Recruiting
        • Ospedale Vito Fazzi
        • Contact:
        • Principal Investigator:
          • Mariangela Ciccarese, MD
    • LU
      • Lido di Camaiore, LU, Italy, 55041
        • Recruiting
        • Ospedale Unico Versilia
        • Contact:
        • Principal Investigator:
          • Domenico Amoroso, MD
    • MN
      • Mantua, MN, Italy, 46100
        • Recruiting
        • Azienda Ospedaliera Carlo Poma
        • Contact:
          • Maria Giovanna Cavazzini, MD
        • Principal Investigator:
          • Maria Giovanna Cavazzini, MD
    • PC
      • Piacenza, PC, Italy, 29121
        • Active, not recruiting
        • Ospedale 'Guglielmo da Saliceto'
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • Fondazione S. Maugeri IRCCS
        • Contact:
        • Principal Investigator:
          • Antonio Bernardo, MD
    • PZ
      • Potenza, PZ, Italy, 85100
        • Recruiting
        • Azienda Ospedaliera S. Carlo
        • Principal Investigator:
          • Domenico Bilancia, MD
        • Contact:
          • Domenico Bilancia, MD
    • Pisa
      • Pisa, Pisa, Italy
        • Recruiting
        • AOU Pisana - Ospedale S. Chiara
        • Contact:
          • Michelotti
    • RM
      • Roma, RM, Italy, 00144
        • Active, not recruiting
        • Istituto Regina Elena per lo studio e la cura dei tumori
    • Reggio Emilia
      • Reggio Emilia, Reggio Emilia, Italy
        • Recruiting
        • Arcispedale Santa Maria Nuova di Reggio Emilia
        • Contact:
          • La Sala
    • SS
      • Sassari, SS, Italy, 07100
        • Recruiting
        • Azienda Ospedaliera n. 1 - Annunziata
        • Contact:
        • Principal Investigator:
          • Antonio Pazzola, MD
    • TO
      • Candiolo, TO, Italy, 10060
        • Recruiting
        • Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
        • Contact:
        • Principal Investigator:
          • Filippo Montemurro, MD
    • Trieste
      • Trieste, Trieste, Italy
        • Recruiting
        • ASS1 Triestina
        • Contact:
          • Ceccherini
    • UD
      • Udine, UD, Italy
        • Recruiting
        • AOU SM Misericordia
        • Contact:
          • Fabio Puglisi
    • VE
      • Negrar, VE, Italy, 37024
        • Recruiting
        • Ospedale Sacro Cuore Don Calabria
        • Contact:
        • Principal Investigator:
          • Stefania Gori, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Young breast cancer patients facing fertility and pregnancy issues

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 15 years
15 years
Rate of patients interested in the available strategies for fertility preservation
Time Frame: 15 years
Assessed through medical records
15 years
Rate of patients undergoing the different strategies for fertility preservation
Time Frame: 15 years
Assessed through medical records
15 years
Type of strategies for fertility preservation proposed by oncologists
Time Frame: 15 years
Assessed through medical records
15 years
Reasons for refusal of the available strategies for fertility preservation
Time Frame: 15 years
Assessed through an open questionnaire
15 years
Type of anticancer therapies administered during pregnancy
Time Frame: 15 years
Assessed through medical records
15 years
Safety: pregnancy complications
Time Frame: 15 years
Assessed through medical records
15 years
Safety: incidence of adverse events
Time Frame: 15 years
Assessed through medical records
15 years
Disease-free survival
Time Frame: 15 years
15 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments
Time Frame: 15 years
15 years
Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved
Time Frame: 15 years
15 years
Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments
Time Frame: 15 years
15 years
Serum hormonal changes during chemotherapy and study follow up
Time Frame: 15 years
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
Time Frame: 15 years
Assessed using obstetric and paediatric medical records
15 years
Obstetrical and paediatric care of children born in breast cancer survivors
Time Frame: 15 years
Assessed using obstetric and paediatric medical records
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinical Research Technology S.r.l.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001377;000650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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