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

Advanced Breast Cancer Clinical Trial

— HERMIONE-13  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173103
• Other study ID #: HERMIONE 13
• Status: Recruiting
• Start date: September 24, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: University of Milano Bicocca
• Contact: Marina Cazzaniga, MD
• Phone: +39 039 2333683
• Email: marina.cazzaniga[@]asst-monza.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms
• HER2-negative Breast Cancer
• Hormone Receptor Positive Breast Carcinoma

Locations

Country	Name	City	State
Italy	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	Milano
Italy	Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda	Milano
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

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Drug toxicities	Evaluation of drug related toxicities listed according to the different therapeutic options	Entire study duration, approximately 12 months
Secondary	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
Secondary	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