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NCT Number: NCT02895165

PREgnancy and FERtility Registry

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Ospedale Cardinal Massaia, Asti, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 15 years

    Assessed through medical records

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

    Time frame: 15 years

    Assessed through medical records

  3. Type of strategies for fertility preservation proposed by oncologists

    Time frame: 15 years

    Assessed through medical records

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

    Time frame: 15 years

    Assessed through an open questionnaire

  5. Type of anticancer therapies administered during pregnancy

    Time frame: 15 years

    Assessed through medical records

  6. Safety: pregnancy complications

    Time frame: 15 years

    Assessed through medical records

  7. Safety: incidence of adverse events

    Time frame: 15 years

    Assessed through medical records

  8. Disease-free survival

    Time frame: 15 years

  9. Overall survival

    Time frame: 15 years

Secondary outcomes

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

    Time frame: 15 years

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

    Time frame: 15 years

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

    Time frame: 15 years

  4. 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

  5. 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

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

    Time frame: 15 years

    Assessed using obstetric and paediatric medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Lucia Del Mastro, MD

CONTACT

[email protected]

+390105558908

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Other

Collaborators

  • Clinical Research Technology S.r.l.

Registry information

Official study title

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

Acronym: PREFER

Important dates

Study start
2012
Primary completion
2027
Study completion
2032
First posted
Sep 9, 2016
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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