Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer

NCT ID: NCT05173103

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 254 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-24
• Study Completion Date: 2024-12-30

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.

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.

Conditions

Advanced Breast Cancer; Hormone Receptor Positive Breast Carcinoma; HER2-negative Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Italy

Other Identifiers

HERMIONE 13

Identifier Type: -

Identifier Source: org_study_id