Registry for pregnancy and fertility in young breast cancer patients
An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)
This study is trying to learn more about how young women with breast cancer can preserve their fertility and manage pregnancy-related issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 23 sites (Asti, Asti and 22 other locations) |
| Trial ID | NCT02895165 on ClinicalTrials.gov |
What this trial studies
The PREgnancy and FERtility (PREFER) program is designed to enhance care and understanding of fertility preservation and pregnancy issues among young women diagnosed with breast cancer. It consists of two main components: PREFER-FERTILITY, which gathers data on fertility preservation preferences and outcomes, and PREFER-PREGNANCY, which focuses on pregnancy-related issues in this patient population. The initiative began at the National Institute for Cancer Research in Italy and has expanded to include multiple institutions under the Gruppo Italiano Mammella study group.
Who should consider this trial
Good fit: Ideal candidates include young women aged 18 to 45 with a breast cancer diagnosis who have not yet undergone radiation or chemotherapy.
Not a fit: Patients with stage IV breast cancer or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve fertility preservation options and pregnancy outcomes for young breast cancer patients.
How similar studies have performed: While the approach is comprehensive, similar studies have shown promise in addressing fertility and pregnancy issues in cancer patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Asti, Asti and 22 other locations
- Ospedale Cardinal Massaia — Asti, Asti, Italy (Recruiting)
- Presidio Ospedaliero 'Antonio Perrino' — Brindisi, Br, Italy (Recruiting)
- AOU di Cagliari Strada — Monserrato, Cagliari, Italy (Active_not_recruiting)
- Azienda Ospedaliera S. Croce e Carle — Cuneo, Cn, Italy (Recruiting)
- Arcispedale S. Anna - A.O.U. di Ferrara — Cona, Fe, Italy (Recruiting)
- Irccs Aou San Martino - Ist — Genoa, Ge, Italy (Recruiting)
- Ospedale Vito Fazzi — Lecce, Le, Italy (Recruiting)
- Ospedale Unico Versilia — Lido di Camaiore, Lu, Italy (Recruiting)
- Azienda Ospedaliera Carlo Poma — Mantua, Mn, Italy (Recruiting)
- Ospedale 'Guglielmo da Saliceto' — Piacenza, PC, Italy (Active_not_recruiting)
- AOU Pisana - Ospedale S. Chiara — Pisa, Pisa, Italy (Recruiting)
- Fondazione S. Maugeri IRCCS — Pavia, Pv, Italy (Recruiting)
- Azienda Ospedaliera S. Carlo — Potenza, Pz, Italy (Recruiting)
- Arcispedale Santa Maria Nuova di Reggio Emilia — Reggio Emilia, Reggio Emilia, Italy (Recruiting)
- Istituto Regina Elena per lo studio e la cura dei tumori — Roma, Rm, Italy (Active_not_recruiting)
- Azienda Ospedaliera n. 1 - Annunziata — Sassari, Ss, Italy (Recruiting)
- Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo — Candiolo, To, Italy (Recruiting)
- ASS1 Triestina — Trieste, Trieste, Italy (Recruiting)
- AOU SM Misericordia — Udine, Ud, Italy (Recruiting)
- Ospedale Sacro Cuore Don Calabria — Negrar, Ve, Italy (Recruiting)
- A.O.U. Federico II — Naples, Italy (Recruiting)
- Istituto Nazionale dei Tumori - Fondazione G.Pascale — Naples, Italy (Recruiting)
- Ospedale Santa Maria della Misericordia — Perugia, Italy (Recruiting)
Study contacts
- Study coordinator: Lucia Del Mastro, MD
- Email: lucia.delmastro@hsanmartino.it
- Phone: +390105558908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.