Clinical trial NCT05173103: Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Breast Cancer
Hormone Receptor Positive Breast Carcinoma
HER2-negative Breast Cancer
Keywords: advanced breast cancer
hormonal therapy
CDK 4/6 inhibitors
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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 \[Palbociclib, Ribociclib or Abemaciclib\]).

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.

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

Primary outcomes:
measure: 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.
timeFrame: Entire study duration, approximately 12 months
Secondary outcomes:
measure: progression-free survival
timeFrame: from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
measure: response rate
timeFrame: Entire study duration, approximately 12 months
measure: Survival Post Progression
timeFrame: from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
measure: progression by location (visceral versus non-visceral).
timeFrame: from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
measure: Drug toxicities
timeFrame: Entire study duration, approximately 12 months
measure: Physician's reasons for treatment choice in real world experience
timeFrame: Entire study duration, approximately 12 months
measure: Predictive factors of response
timeFrame: Entire study duration, approximately 12 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Clinica Oncologica Aou Ospedali Riuniti
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia Asti
city: Belluno
country: Italy
facility: Ospedale San Martino
city: Benevento
country: Italy
facility: OSPEDALE Sacro Cuore di Gesù - Fatebenefratelli
city: Brescia
country: Italy
facility: Spedali Civili Brescia
city: Como
country: Italy
facility: Ospedale Sant'Anna, San Fermo della Battaglia
city: Cremona
country: Italy
facility: ASST Cremona - Area Donna
city: Gallarate
country: Italy
facility: ASST VALLE OLONA - Presidio Gallarate - SC Oncologia
city: Legnano
country: Italy
facility: A.S.S.T. Ovest Milanese
city: Livorno
country: Italy
facility: Ospedale Civile di Livorno, Azienda USL Toscana Nord Ovest
city: Meldola
country: Italy
facility: ISTITUTO ROMAGNOLO per la cura e lo studio dei tumori (IRST-IRCCS)
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Milano
country: Italy
facility: Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Olbia
country: Italy
facility: UO Aziendale Olbia
city: Palermo
country: Italy
facility: Ospedale La Maddalena
city: Pavia
country: Italy
facility: ICS Maugeri Spa-SB PAVIA
city: Piacenza
country: Italy
facility: U.O.C Oncologia Ospedale "G Da Saliceto"
city: Pisa
country: Italy
facility: UO Oncologia Medica I Azienda Ospedaliero Universitaria Pisana
city: Reggio Emilia
country: Italy
facility: Azienda USL - Arcispedale S. Maria Nuova IRCCS
city: Rho
country: Italy
facility: A.S.S.T. Rhodense Ospedale Di Circolo Rho
city: Rimini
country: Italy
facility: Oncologia Ospedale di Rimini
city: Roma
country: Italy
facility: IRCCS Istituto Nazionale Tumori - IFO Regina Elena, Oncologia Medica B
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Torino
country: Italy
facility: AOU città della scienza e della salute SCDO4
city: Torino
country: Italy
facility: AOU città della scienza e della salute SCDU1
city: Trento
country: Italy
facility: Oncologia Trento
city: Tricase
country: Italy
facility: PIA FONDAZIONE Cardinale PANICO Tricase - Lecce
city: Varese
country: Italy
facility: ASST SETTELAGHI - Oncologia Varese
Study officials:
References: