NCT Number: NCT05173103
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.
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Female
Observational
Clinica Oncologica Aou Ospedali Riuniti, Ancona, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Entire study duration, approximately 12 months
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.
Time frame: from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
time from the start of treatment to evidence of disease progression or death
Time frame: Entire study duration, approximately 12 months
radiological response rate according to RECIST criteria, classified as CR (Complete Response), PR (Partial Response), SD (Stable Disease), PD (Progressive Disease)
Time frame: from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
survival evaluated from from date of treatment beginning until the date of first documented progression or date of death from any cause
Time frame: from date of treatment beginning until the date of first documented progression or date of death from any cause, assessed up to 72 months
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
Time frame: Entire study duration, approximately 12 months
Evaluation of drug related toxicities listed according to the different therapeutic options
Time frame: Entire study duration, approximately 12 months
Evaluation of the physician's reasons for treatment choice of the second-line therapy after progression to CDK4 / 6i associated with hormonal therapy
Time frame: Entire study duration, approximately 12 months
Evaluation of predictive factors of response through the comparison of four variables according to AIC e R2 criteria
University of Milano Bicocca
Other
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)
Acronym: HERMIONE-13
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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