Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
HERMIONE-13
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)
1 other identifier
observational
254
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2021
CompletedFirst Submitted
Initial submission to the registry
November 19, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJuly 25, 2025
December 1, 2023
2.4 years
November 19, 2021
July 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Description of the choices for second line treatment in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in association with hormonal therapy.
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.
Entire study duration, approximately 12 months
Secondary Outcomes (7)
progression-free survival
from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
response rate
Entire study duration, approximately 12 months
Survival Post Progression
from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
progression by location (visceral versus non-visceral).
from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
Drug toxicities
Entire study duration, approximately 12 months
- +2 more secondary outcomes
Eligibility Criteria
The study involves the analysis of patients with HR + / HER2- advanced breast cancer treated in the second line after initial treatment failure (aromatase inhibitor or Fulvestrant + CDK4 / 6i \[Palbociclib, Ribociclib or Abemaciclib\]).
You may qualify if:
- 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
You may not qualify if:
- age \<18 years
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Clinica Oncologica Aou Ospedali Riuniti
Ancona, Italy
Ospedale Cardinal Massaia Asti
Asti, Italy
Ospedale San Martino
Belluno, Italy
OSPEDALE Sacro Cuore di Gesù - Fatebenefratelli
Benevento, Italy
Spedali Civili Brescia
Brescia, Italy
Ospedale Sant'Anna, San Fermo della Battaglia
Como, Italy
ASST Cremona - Area Donna
Cremona, Italy
ASST VALLE OLONA - Presidio Gallarate - SC Oncologia
Gallarate, Italy
A.S.S.T. Ovest Milanese
Legnano, Italy
Ospedale Civile di Livorno, Azienda USL Toscana Nord Ovest
Livorno, Italy
ISTITUTO ROMAGNOLO per la cura e lo studio dei tumori (IRST-IRCCS)
Meldola, Italy
ASST Fatebenefratelli Sacco
Milan, Italy
Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda
Milan, Italy
Ospedale San Gerardo
Monza, Italy
UO Aziendale Olbia
Olbia, Italy
Ospedale La Maddalena
Palermo, Italy
ICS Maugeri Spa-SB PAVIA
Pavia, Italy
U.O.C Oncologia Ospedale "G Da Saliceto"
Piacenza, Italy
UO Oncologia Medica I Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda USL - Arcispedale S. Maria Nuova IRCCS
Reggio Emilia, Italy
A.S.S.T. Rhodense Ospedale Di Circolo Rho
Rho, Italy
Oncologia Ospedale di Rimini
Rimini, Italy
IRCCS Istituto Nazionale Tumori - IFO Regina Elena, Oncologia Medica B
Roma, Italy
Policlinico Gemelli
Roma, Italy
AOU città della scienza e della salute SCDO4
Torino, Italy
AOU città della scienza e della salute SCDU1
Torino, Italy
Oncologia Trento
Trento, Italy
PIA FONDAZIONE Cardinale PANICO Tricase - Lecce
Tricase, Italy
ASST SETTELAGHI - Oncologia Varese
Varese, Italy
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2021
First Posted
December 29, 2021
Study Start
September 24, 2021
Primary Completion
January 30, 2024
Study Completion
December 30, 2024
Last Updated
July 25, 2025
Record last verified: 2023-12