AzTrials
AzTrials

Breast NeoplasmsPREFERNCT02895165

PREgnancy and FERtility Registry

An observational study of Breast Neoplasms and Pregnancy, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 23 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
How many people
1,000 participants
Where
23 sitesItaly
Study dates
Nov 2012to Nov 2032
How long will I take part?
15 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Young breast cancer patients facing fertility and pregnancy issues

Who may be able to join

  • 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

Who cannot join

  • inability to provide written informed consent
  • stage IV disease at diagnosis (only for PREFER-FERTILITY)
  • serious psychiatric disorders

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lucia Del Mastro, MD contact

+390105558908

lucia.delmastro@hsanmartino.it

23 sites in 1 country

Italy23 sites, 20 recruiting

  • Ospedale Cardinal Massaia

    Asti, Asti

    Testore

    Recruiting

  • Presidio Ospedaliero 'Antonio Perrino'

    Brindisi, BR, 72100

    Saverio Cinieri, MD, 00390831537219, saverio.cinieri@ieo.it

    Saverio Cinieri, MD

    Recruiting

  • Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo

    Candiolo, TO, 10060

    Filippo Montemurro, MD, 00390119933250, filippo.montemurro@ircc.it

    Filippo Montemurro, MD

    Recruiting

  • Arcispedale S. Anna - A.O.U. di Ferrara

    Cona, FE, 44124

    Antonio Frassoldati, MD, 00390532239209, a.frassoldati@ospfe.it

    Antonio Frassoldati, MD

    Recruiting

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, CN, 12100

    Ornella Garrone, MD, 00390171616350, ornella.garrone@gmail.com

    Ornella Garrone, MD

    Recruiting

  • Irccs Aou San Martino - Ist

    Genoa, GE, 16132

    Lucia Del Mastro, MD, 00390105600387, lucia.delmastro@hsanmartino.it

    Lucia Del Mastro, MD

    Recruiting

  • Ospedale Vito Fazzi

    Lecce, LE, 73100

    Mariangela Ciccarese, MD, 00390832661962, m.ciccarese@libero.it

    Mariangela Ciccarese, MD

    Recruiting

  • Ospedale Unico Versilia

    Lido di Camaiore, LU, 55041

    Domenico Amoroso, MD, 003905846057208, d.amoroso@usl12.toscana.it

    Domenico Amoroso, MD

    Recruiting

  • Azienda Ospedaliera Carlo Poma

    Mantua, MN, 46100

    Maria Giovanna Cavazzini, MD

    Maria Giovanna Cavazzini, MD

    Recruiting

  • AOU di Cagliari Strada

    Monserrato, Cagliari

    Active, not recruiting

  • A.O.U. Federico II

    Naples, 80131

    Sabino De Placido, MD, 00390817463650, studiclinici.oncologia@unina.it

    Sabino De Placido, MD

    Recruiting

  • Istituto Nazionale dei Tumori - Fondazione G.Pascale

    Naples, 80131

    Michelino De Laurentiis, MD, 00390815454999, m.delaurentiis@breastunit.org

    Michelino De Laurentiis, MD

    Recruiting

  • Ospedale Sacro Cuore Don Calabria

    Negrar, VE, 37024

    Stefania Gori, MD, 00390456013472, stefania.gori@sacrocuore.it

    Stefania Gori, MD

    Recruiting

  • Fondazione S. Maugeri IRCCS

    Pavia, PV, 27100

    Antonio Bernardo, MD, 00390382592640, antonio.bernardo@fsm.it

    Antonio Bernardo, MD

    Recruiting

  • Ospedale Santa Maria della Misericordia

    Perugia

    Crinò

    Recruiting

  • Ospedale 'Guglielmo da Saliceto'

    Piacenza, PC, 29121

    Active, not recruiting

  • AOU Pisana - Ospedale S. Chiara

    Pisa, Pisa

    Michelotti

    Recruiting

  • Azienda Ospedaliera S. Carlo

    Potenza, PZ, 85100

    Domenico Bilancia, MD

    Domenico Bilancia, MD

    Recruiting

  • Arcispedale Santa Maria Nuova di Reggio Emilia

    Reggio Emilia, Reggio Emilia

    La Sala

    Recruiting

  • Istituto Regina Elena per lo studio e la cura dei tumori

    Roma, RM, 00144

    Active, not recruiting

  • Azienda Ospedaliera n. 1 - Annunziata

    Sassari, SS, 07100

    Antonio Pazzola, MD, 00390792061556, oncologia.medica@aslsassari.it

    Antonio Pazzola, MD

    Recruiting

  • ASS1 Triestina

    Trieste, Trieste

    Ceccherini

    Recruiting

  • AOU SM Misericordia

    Udine, UD

    Fabio Puglisi

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Keywords
breast neoplasms, fertility preservation, pregnancy
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients interested in the available strategies for fertility preservation

    Assessed through medical records

    Measured: 15 years

  2. Rate of patients undergoing the different strategies for fertility preservation

    Assessed through medical records

    Measured: 15 years

  3. Type of strategies for fertility preservation proposed by oncologists

    Assessed through medical records

    Measured: 15 years

  4. Reasons for refusal of the available strategies for fertility preservation

    Assessed through an open questionnaire

    Measured: 15 years

  5. Type of anticancer therapies administered during pregnancy

    Assessed through medical records

    Measured: 15 years

  6. Safety: pregnancy complications

    Assessed through medical records

    Measured: 15 years

  7. Safety: incidence of adverse events

    Assessed through medical records

    Measured: 15 years

  8. Disease-free survival

    Measured: 15 years

  9. Overall survival

    Measured: 15 years

Secondary outcomes (6)

  1. Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments

    Measured: 15 years

  2. Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved

    Measured: 15 years

  3. Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments

    Measured: 15 years

  4. 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

    Measured: 15 years

  5. Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments

    Assessed using obstetric and paediatric medical records

    Measured: 15 years

  6. Obstetrical and paediatric care of children born in breast cancer survivors

    Assessed using obstetric and paediatric medical records

    Measured: 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2016 (estimated)
  2. Study startNov 2012
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02895165
Sponsor's protocol ID
001377;000650
Acronym
PREFER
Status last verified
Apr 2026
First submitted
22 Aug 2016
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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/s12885-017-3348-8.

    PubMed 28526012

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms and Pregnancy, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 23 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lucia Del Mastro, MD (+390105558908, lucia.delmastro@hsanmartino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients interested in the available strategies for fertility preservation (time frame: 15 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02895165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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