Advanced Breast CarcinomaCYCLHERNCT06243432
Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer
An observational study of Advanced Breast Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Carcinoma
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 1 Mar 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HR+/HER2- advanced breast cancer patients
Who may be able to join
- Age ≥ 18 yo
- Histological diagnosis of HR+/HER2- advanced breast cancer
- Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)
- Immunohistochemical expression levels of estrogen and progesterone receptors
- First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020
- Signing of informed consent approved by local Ethic Committee
Who cannot join
- Absence of clinical and pathological data that would compromise the definition of the study endpoints
- HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease
- Previous chemotherapy for treatment of metastatic disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico A. Gemelli - IRCCS
Rome, 00168
Alessandra Fabi, +390630157337, alessandra.fabi@policlinicogemelli.it
Alessandra Fabi, +390630156124, alessandra.fabi@policlinicogemelli.it
About this study
Official title: Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer: Correlation to Therapeutic Efficacy of Cycline-Dependent Kinase Inhibitors(CDK4/6) as First Line Treatment. CYCLHER Study
CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.
- Conditions
- Advanced Breast Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS of HR+/HER2- breast cancer patients who received endocrine treatment plus CDK4/6 inhibitor as first line treatment for metastatic disease, categorized according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
Measured: Through study completion, an average of 1 year".
Secondary outcomes (3)
Objective response rate (ORR)
ORR according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
Measured: Through study completion, an average of 1 year".
Overall survival (OS)
OS according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
Measured: Through study completion, an average of 1 year".
Incidence of Adverse Events (AEs)
AEs related to the treatment and evaluated according to CTCAE v5.0
Measured: Through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandra Fabi, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243432
- Sponsor's protocol ID
- 5519
- Acronym
- CYCLHER
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer: Correlation to Therapeutic Efficacy of Cycline-Dependent Kinase Inhibitors(CDK4/6) as First Line Treatment. CYCLHER Study
- ClinicalTrials.gov ID
- NCT06243432
- Acronym / sponsor ID
- CYCLHER / 5519
- Conditions
- Advanced Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 6 Feb 2024 (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.
CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HR+/HER2- advanced breast cancer patients
Key inclusion criteria (6 listed)
- Age ≥ 18 yo
- Histological diagnosis of HR+/HER2- advanced breast cancer
- Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)
- Immunohistochemical expression levels of estrogen and progesterone receptors
- First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020
Key exclusion criteria (3 listed)
- Absence of clinical and pathological data that would compromise the definition of the study endpoints
- HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease
- Previous chemotherapy for treatment of metastatic disease
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
Progression free survival (PFS)
Time frame: Through study completion, an average of 1 year".
PFS of HR+/HER2- breast cancer patients who received endocrine treatment plus CDK4/6 inhibitor as first line treatment for metastatic disease, categorized according to estrogen and progesterone receptor levels and HER2 expression status (HER2 0,1+ or 2+ FISH negative).
3 secondary outcomes
Objective response rate (ORR)
Time frame: Through study completion, an average of 1 year".
Overall survival (OS)
Time frame: Through study completion, an average of 1 year".
Incidence of Adverse Events (AEs)
Time frame: Through study completion, an average of 1 year".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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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.
Alessandra Fabi, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site 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 Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Fabi, MD (0039 0630157337, alessandra.fabi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Through study completion, an average of 1 year".). 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 24 Apr 2024.