NCT05173103Completed
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
Multicenter Retrospective Observational (Descriptive) Study of Second-line Therapies After Progression to CDK4/6i in Association With Hormone Therapy, in Patients With HR+/HER2- Advanced Breast Cancer (HERMIONE 13)
Source: ClinicalTrials.gov · Last updated 25 Jul 2025
Brief summary (registry, in English)
Description of the choices for second line treatment, in the normal clinical practice of the centers adhering to the Hermione Network, in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in association with hormonal therapy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 254 (actual)
- First submitted
- 19 Nov 2021
- Start date
- Sept 2021
- Primary completion date
- Jan 2024
- Lead sponsor
- University of Milano Bicocca
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05173103
What you commit to
- Study type: Observational
- Participants enrolled: 254
- From Sept 2021 to the primary completion date, Jan 2024
- 29 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous neoplastic pathology, within 5 years of the last active treatment
- Previous chemotherapy treatments, with biological or endocrine therapies for advanced disease, different from first-line therapy with OT + CDK4 / 6i
Age
- age \<18 years
Who the study is looking for
- age\> 18 years
- female sex
- Performance Status (ECOG) 0-2;
- hormonal-receptor positive breast cancer (Estrogen and / or Progesterone positive), HER2 negative, with evidence of stage IV / locally advanced inoperable disease
- Radiologically documented progression in 1st line treatment with Hormonal Therapy (Aromatase inhibitor / Fulvestrant) + CDK4-6i (Palbociclib / Ribociclib / Abemaciclib)
- Execution of at least one subsequent therapeutic line chosen by the clinician, with at least one radiological re-evaluation during this treatment by 31 December 2020.
- Radiologically measurable or evaluable lesions
- Written informed consent
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Oncologica Aou Ospedali Riuniti Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Ospedale Cardinal Massaia Asti Coordinator of this site? Confirm its status | Asti | Italy | Unknown status |
| Ospedale San Martino Coordinator of this site? Confirm its status | Belluno | Italy | Unknown status |
| OSPEDALE Sacro Cuore di Gesù - Fatebenefratelli Coordinator of this site? Confirm its status | Benevento | Italy | Unknown status |
| Spedali Civili Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Ospedale Sant'Anna, San Fermo della Battaglia Coordinator of this site? Confirm its status | Como | Italy | Unknown status |
| ASST Cremona - Area Donna Coordinator of this site? Confirm its status | Cremona | Italy | Unknown status |
| ASST VALLE OLONA - Presidio Gallarate - SC Oncologia Coordinator of this site? Confirm its status | Gallarate | Italy | Unknown status |
| A.S.S.T. Ovest Milanese Coordinator of this site? Confirm its status | Legnano | Italy | Unknown status |
| Ospedale Civile di Livorno, Azienda USL Toscana Nord Ovest Coordinator of this site? Confirm its status | Livorno | Italy | Unknown status |
| ISTITUTO ROMAGNOLO per la cura e lo studio dei tumori (IRST-IRCCS) Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale San Gerardo Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| UO Aziendale Olbia Coordinator of this site? Confirm its status | Olbia | Italy | Unknown status |
| Ospedale La Maddalena Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| ICS Maugeri Spa-SB PAVIA Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| U.O.C Oncologia Ospedale "G Da Saliceto" Coordinator of this site? Confirm its status | Piacenza | Italy | Unknown status |
| UO Oncologia Medica I Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Azienda USL - Arcispedale S. Maria Nuova IRCCS Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| A.S.S.T. Rhodense Ospedale Di Circolo Rho Coordinator of this site? Confirm its status | Rho | Italy | Unknown status |
| Oncologia Ospedale di Rimini Coordinator of this site? Confirm its status | Rimini | Italy | Unknown status |
| IRCCS Istituto Nazionale Tumori - IFO Regina Elena, Oncologia Medica B Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| AOU città della scienza e della salute SCDU1 Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| AOU città della scienza e della salute SCDO4 Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Oncologia Trento Coordinator of this site? Confirm its status | Trento | Italy | Unknown status |
| PIA FONDAZIONE Cardinale PANICO Tricase - Lecce Coordinator of this site? Confirm its status | Tricase | Italy | Unknown status |
| ASST SETTELAGHI - Oncologia Varese Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.