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)

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.

Study Overview

• Status: Completed
• Conditions: Advanced Breast Cancer; Hormone Receptor Positive Breast Carcinoma; HER2-negative Breast Cancer

Detailed Description

Multicenter retrospective observational study, describing therapeutic choices as second-line treatment in patients with HR + / HER2- advanced breast cancer in a real world setting, in centers adhering to the Hermione Network.

The study involves the analysis of patients with HR + / HER2- advanced breast cancer treated in second line after initial treatment failure with aromatase inhibitor or Fulvestrant + CDK4 / 6i (Palbociclib, Ribociclib or Abemaciclib).

Data will be collected from 150 patients with at least one radiological re-evaluation of disease during 2nd-line treatment from 01 January 2016 until 31 December 2020.

List of collected information: Patients' characteristics (gender, age at diagnosis, menopausal state); Disease definition at diagnosis (stage, tumour histology, hormonal status); Surgery (date of surgery, type of surgical approach); Neo-adjuvant treatment; Adjuvant treatment; Date of first relapse (and time since the end of adjuvant therapy); Locations of metastases, Biopsy of metastases, Hormonal receptor status; First-line treatment, hormonal therapy, Best response, Cause of treatment end; Second-line treatment, Best response (radiological re-evaluation), Toxicity, Cause of treatment end.

Demographics, baseline characteristics (including tumor characteristics) and treatment information will be summarized descriptively. The categorical variables will be presented in the form of frequencies and percentages, while the continuous variables will be presented by mean, standard deviation and minimum and maximum values.

A logistic model will be used for the analysis of clinical benefit (categorical variable), while for the analysis of time-to-event indicators a proportional hazard model will be used. For both analyses, the optimal model will be chosen with the method of "backward" selection. A threshold value of 5% will be used to include predictive variables in the model. The estimates derived by the final models will be evaluated using a penalized model for the evaluation of maximal probability, according to the Firth approach.

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Clinica Oncologica Aou Ospedali Riuniti
  • Asti, Italy
    • Ospedale Cardinal Massaia Asti
  • Belluno, Italy
    • Ospedale San Martino
  • Benevento, Italy
    • OSPEDALE Sacro Cuore di Gesù - Fatebenefratelli
  • Brescia, Italy
    • Spedali Civili Brescia
  • Como, Italy
    • Ospedale Sant'Anna, San Fermo della Battaglia
  • Cremona, Italy
    • ASST Cremona - Area Donna
  • Gallarate, Italy
    • ASST VALLE OLONA - Presidio Gallarate - SC Oncologia
  • Legnano, Italy
    • A.S.S.T. Ovest Milanese
  • Livorno, Italy
    • Ospedale Civile di Livorno, Azienda USL Toscana Nord Ovest
  • Meldola, Italy
    • ISTITUTO ROMAGNOLO per la cura e lo studio dei tumori (IRST-IRCCS)
  • Milano, Italy
    • Asst Fatebenefratelli Sacco
  • Milano, Italy
    • Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda
  • Monza, Italy
    • Ospedale San Gerardo
  • Olbia, Italy
    • UO Aziendale Olbia
  • Palermo, Italy
    • Ospedale La Maddalena
  • Pavia, Italy
    • ICS Maugeri Spa-SB PAVIA
  • Piacenza, Italy
    • U.O.C Oncologia Ospedale "G Da Saliceto"
  • Pisa, Italy
    • UO Oncologia Medica I Azienda Ospedaliero Universitaria Pisana
  • Reggio Emilia, Italy
    • Azienda USL - Arcispedale S. Maria Nuova IRCCS
  • Rho, Italy
    • A.S.S.T. Rhodense Ospedale Di Circolo Rho
  • Rimini, Italy
    • Oncologia Ospedale di Rimini
  • Roma, Italy
    • Policlinico Gemelli
  • Roma, Italy
    • IRCCS Istituto Nazionale Tumori - IFO Regina Elena, Oncologia Medica B
  • Torino, Italy
    • AOU città della scienza e della salute SCDO4
  • Torino, Italy
    • AOU città della scienza e della salute SCDU1
  • Trento, Italy
    • Oncologia Trento
  • Tricase, Italy
    • PIA FONDAZIONE Cardinale PANICO Tricase - Lecce
  • Varese, Italy
    • ASST SETTELAGHI - Oncologia Varese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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]).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	time from the start of treatment to evidence of disease progression or death	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	radiological response rate according to RECIST criteria, classified as CR (Complete Response), PR (Partial Response), SD (Stable Disease), PD (Progressive Disease)	Entire study duration, approximately 12 months
Survival Post Progression	survival evaluated from from date of treatment beginning until the date of first documented progression or date of death from any cause	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).	time from the date second-line treatment beginning to the date of disease progression or death from any cause, stratified according to visceral versus non-visceral diseaes	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	Evaluation of drug related toxicities listed according to the different therapeutic options	Entire study duration, approximately 12 months
Physician's reasons for treatment choice in real world experience	Evaluation of the physician's reasons for treatment choice of the second-line therapy after progression to CDK4 / 6i associated with hormonal therapy	Entire study duration, approximately 12 months
Predictive factors of response	Evaluation of predictive factors of response through the comparison of four variables according to AIC e R2 criteria	Entire study duration, approximately 12 months

Collaborators and Investigators

• Sponsor: University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: hormonal therapy; advanced breast cancer; CDK 4/6 inhibitors
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HERMIONE 13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No