Breast CancerBRAVE-CyclinNCT07008508
Incidence of Venous Thromboembolism and Cardiovascular Events in Breast Cancer Patients Undergoing Cyclin-dependent Kinase 4/6 Inhibitors: The Breast Cancer Associated Vascular Events During Cyclin-dependent Kinase 4/6 Inhibitors Therapy (BRAVE-Cyclin) Study
An observational study of Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
"Incidence of Venous Thromboembolism and Cardiovascular Events in Patients with Breast Cancer Treated with Cyclin-Dependent Kinase Inhibitors 4/6, the BRAVE-Cyclin Study" is national, single-center, observational, prospective cohort study, conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cyclin-dependent Kinase 4/6 Inhibitor
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2025to May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Study population will consist of subsequent patients prospectively enrolled in case of indication of systemic antineoplastic treatment with CDK 4/6 Inhibitor for advanced breast cancer. Patients will be recruited in the setting of the Gynecologic Oncology Day Hospital and evaluated by the U.O.S.D Percorso Trombosi of the Agostino Gemelli University Polyclinic Foundation I.R.C.C.S. in Rome.
Who may be able to join
- Female sex;
- Diagnosis of advanced or metastatic breast cancer.
- Indication for therapy with Cyclin-dependent Kinase 4/6 Inhibitor, as clinical practice;
- Age of 18 years or older;
- Signing Informed Consent.
Who cannot join
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
About this study
"Incidence of Venous Thromboembolism and Cardiovascular Events in Patients with Breast Cancer Treated with Cyclin-Dependent Kinase Inhibitors 4/6, the BRAVE-Cyclin Study" is national, single-center, observational, prospective cohort study, conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS.
According to recent evidence, patients with advanced or metastatic breast cancer receiving cyclin-dependent kinase (CDK) 4/6 inhibitors - ribociclib, palbociclib, and abemaciclib - may have an increased risk of arterial or venous thrombosis.
Read more
Currently, there are no validated tools to stratify breast cancer patients receiving CDK 4/6 inhibitors according to their thromboembolic or cardiovascular risk.
The prospective BRAVE-Cyclin study aims to evaluate the incidence of venous thromboembolism, major cardiovascular events, and major adverse peripheral vascular events in breast cancer patients receiving CDK 4/6 inhibitors.
The objective is to identify the main determinants of thromboembolic and cardiovascular risk, thus improving risk stratification and management strategies.
- Conditions
- Breast Cancer
- Being tested
- Cyclin-dependent Kinase 4/6 Inhibitor
- Keywords
- venous thromboembolism, breast cancer, Cyclin-dependent Kinase 4/6 Inhibitors, CDK 4/6 Inhibitors, cardiovascular disease, Palbociclib, Ribociclib, Abemaciclib
- Medical subject headings
- Breast Neoplasms, Venous Thromboembolism, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclin-dependent Kinase 4/6 InhibitorDrug
Also called Palbociclib, Abemaciclib, Ribociclib
Planned new line of Cyclin-dependent Kinase 4/6 Inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
• Incidence rate of vascular events
Vascular events are defined as episodes of Venous Thromboembolism (VTE) in usual or unusual site, Major Adverse Cardiovascular Events (MACE), and/or Major Adverse Limbs Events (MALE)
Measured: From enrollment to the end of 60 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start15 May 2025
- Primary completionMay 2032 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pola Roberto, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008508
- Sponsor's protocol ID
- ID7674
- Acronym
- BRAVE-Cyclin
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Venous Thromboembolism and Cardiovascular Events in Breast Cancer Patients Undergoing Cyclin-dependent Kinase 4/6 Inhibitors: The Breast Cancer Associated Vascular Events During Cyclin-dependent Kinase 4/6 Inhibitors Therapy (BRAVE-Cyclin) Study
- ClinicalTrials.gov ID
- NCT07008508
- Acronym / sponsor ID
- BRAVE-Cyclin / ID7674
- Conditions
- Breast Cancer
- Keywords
- venous thromboembolism, breast cancer, Cyclin-dependent Kinase 4/6 Inhibitors, CDK 4/6 Inhibitors, cardiovascular disease, Palbociclib, Ribociclib, Abemaciclib
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- May 2032 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 6 Jun 2025 (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.
"Incidence of Venous Thromboembolism and Cardiovascular Events in Patients with Breast Cancer Treated with Cyclin-Dependent Kinase Inhibitors 4/6, the BRAVE-Cyclin Study" is national, single-center, observational, prospective cohort study, conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS.
According to recent evidence, patients with advanced or metastatic breast cancer receiving cyclin-dependent kinase (CDK) 4/6 inhibitors - ribociclib, palbociclib, and abemaciclib - may have an increased risk of arterial or venous thrombosis.
Currently, there are no validated tools to stratify breast cancer patients receiving CDK 4/6 inhibitors according to their thromboembolic or cardiovascular risk.
The prospective BRAVE-Cyclin study aims to evaluate the incidence of venous thromboembolism, major cardiovascular events, and major adverse peripheral vascular events in breast cancer patients receiving CDK 4/6 inhibitors.
The objective is to identify the main determinants of thromboembolic and cardiovascular risk, thus improving risk stratification and management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will consist of subsequent patients prospectively enrolled in case of indication of systemic antineoplastic treatment with CDK 4/6 Inhibitor for advanced breast cancer. Patients will be recruited in the setting of the Gynecologic Oncology Day Hospital and evaluated by the U.O.S.D Percorso Trombosi of the Agostino Gemelli University Polyclinic Foundation I.R.C.C.S. in Rome.
Key inclusion criteria (5 listed)
- Female sex;
- Diagnosis of advanced or metastatic breast cancer.
- Indication for therapy with Cyclin-dependent Kinase 4/6 Inhibitor, as clinical practice;
- Age of 18 years or older;
- Signing Informed Consent.
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclin-dependent Kinase 4/6 InhibitorAlso: Palbociclib, Abemaciclib, RibociclibPlanned new line of Cyclin-dependent Kinase 4/6 Inhibitor | Drug | – |
Primary outcome
• Incidence rate of vascular events
Time frame: From enrollment to the end of 60 months follow-up
Vascular events are defined as episodes of Venous Thromboembolism (VTE) in usual or unusual site, Major Adverse Cardiovascular Events (MACE), and/or Major Adverse Limbs Events (MALE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer, 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
• Incidence rate of vascular events (time frame: From enrollment to the end of 60 months follow-up). 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 6 Jun 2025.