Advanced Breast CancerHERMIONE-13NCT05173103
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
An observational study of Advanced Breast Cancer and Hormone Receptor Positive Breast Carcinoma, run by University of Milano Bicocca at 29 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer, Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
- How many people
- 254 participants
- Where
- 29 sitesItaly
- Study dates
- 24 Sep 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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]).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Italy29 sites
Clinica Oncologica Aou Ospedali Riuniti
Ancona
Ospedale Cardinal Massaia Asti
Asti
Ospedale San Martino
Belluno
OSPEDALE Sacro Cuore di Gesù - Fatebenefratelli
Benevento
Spedali Civili Brescia
Brescia
Ospedale Sant'Anna, San Fermo della Battaglia
Como
ASST Cremona - Area Donna
Cremona
ASST VALLE OLONA - Presidio Gallarate - SC Oncologia
Gallarate
A.S.S.T. Ovest Milanese
Legnano
Ospedale Civile di Livorno, Azienda USL Toscana Nord Ovest
Livorno
ISTITUTO ROMAGNOLO per la cura e lo studio dei tumori (IRST-IRCCS)
Meldola
ASST Fatebenefratelli Sacco
Milan
Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda
Milan
Ospedale San Gerardo
Monza
UO Aziendale Olbia
Olbia
Ospedale La Maddalena
Palermo
ICS Maugeri Spa-SB PAVIA
Pavia
U.O.C Oncologia Ospedale "G Da Saliceto"
Piacenza
UO Oncologia Medica I Azienda Ospedaliero Universitaria Pisana
Pisa
Azienda USL - Arcispedale S. Maria Nuova IRCCS
Reggio Emilia
A.S.S.T. Rhodense Ospedale Di Circolo Rho
Rho
Oncologia Ospedale di Rimini
Rimini
IRCCS Istituto Nazionale Tumori - IFO Regina Elena, Oncologia Medica B
Roma
Policlinico Gemelli
Roma
AOU città della scienza e della salute SCDO4
Torino
AOU città della scienza e della salute SCDU1
Torino
Oncologia Trento
Trento
PIA FONDAZIONE Cardinale PANICO Tricase - Lecce
Tricase
ASST SETTELAGHI - Oncologia Varese
Varese
About this study
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)
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.
Read the 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
- Keywords
- advanced breast cancer, hormonal therapy, CDK 4/6 inhibitors
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Entire study duration, approximately 12 months
Secondary outcomes (7)
progression-free survival
time from the start of treatment to evidence of disease progression or death
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Entire study duration, approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start24 Sep 2021
- Primary completion30 Jan 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173103
- Sponsor's protocol ID
- HERMIONE 13
- Acronym
- HERMIONE-13
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05173103
- Acronym / sponsor ID
- HERMIONE-13 / HERMIONE 13
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
- Keywords
- advanced breast cancer, hormonal therapy, CDK 4/6 inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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]).
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
7 secondary outcomes
progression-free survival
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
response rate
Time frame: Entire study duration, approximately 12 months
Survival Post Progression
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
progression by location (visceral versus non-visceral).
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
Drug toxicities
Time frame: Entire study duration, approximately 12 months
Physician's reasons for treatment choice in real world experience
Time frame: Entire study duration, approximately 12 months
Predictive factors of response
Time frame: Entire study duration, approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Breast Cancer and Hormone Receptor Positive Breast Carcinoma, run by University of Milano Bicocca at 29 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Entire study duration, approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.