Breast CancerNCT07399808
CDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study
An observational study of Breast Cancer and Old Age, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Breast cancer is one of the tumors with the highest incidence and current evidence indicates a higher prevalence in elderly patients (≥70 years) with a higher mortality rate due to immunosenescence, diagnostic delay and under treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Old Age
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2025to Dec 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this cross-sectional study includes patients followed at the Medical Oncology Foundation IRCCS Policlinico San Matteo Pavia and Medical Oncology ICS Maugeri Pavia, suffering from solid tumors subjected to active systemic treatment with CDK4/6 for the disease in the adjuvant phase
Who may be able to join
- age over 18 years
- patients with solid tumours undergoing active systemic treatment with CDK4/6 for adjuvant disease
Who cannot join
- Patients who are unable to understand informed consent document
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
Angioletta Lasagna, +39 0382502523, a.lasagna@smatteo.pv.it
comitato.bioetica@smatteo.pv.it
About this study
Breast cancer is one of the tumors with the highest incidence and current evidence indicates a higher prevalence in elderly patients (≥70 years) with a higher mortality rate due to immunosenescence, diagnostic delay and under treatment. Elderly patients are still poorly represented in clinical trials and the main indications for the treatment of the elderly population are extrapolated from the guidelines used in studies conducted predominantly on the younger population. In particular, these guidelines do not take into account the significant variability of elderly patients, in particular their comorbidities, performance status, physiological age and frailty.
The aim of this study is to improve understanding of the clinical efficacy and safety of CDK 4/6i in older women in a real-world setting compared to younger women.
- Conditions
- Breast Cancer, Old Age
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i.
The primary objective of this study will be to evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during CDK 4/6i administration. The primary endpoint will be the estimated incidence of toxicity (haematological and/or non-haematological) of any grade over a 12-month time window in elderly MBC and EBC patients (≥70 years) from our cohort of cancer patients treated with CDK 4/6i.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (4)
Compare the toxicity rate between elderly and young MBC subjects;
The ratio of the toxicity rates (hematological and/or non hematological) of any degree over a time window of 12 months between elderly and younger EBC patients.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the rate of switch therapies between elderly and younger EBC subjects;
the ratio of patients who switched therapy to the total number of treated patients.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the rate of dose reductions between elderly and younger EBC subjects;
The ratio of patients who had a dose reduction to total number of treated patients.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the invasive disease free survival (iDFS) between elderly and younger EBC subjects.
The iDFS: calculated from the date of CDK 4/6i initiation to the date of first occurrence of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second primary nonbreast invasive cancer.
Measured: from the date of CDK 4/6i initiation to the date of first occurrence of ipsilateral invasive breast tumor recurrence, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start21 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (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 IRCCS Policlinico San Matteo di PaviaThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angioletta Lasagna, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399808
- Sponsor's protocol ID
- BC_EP
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study
- ClinicalTrials.gov ID
- NCT07399808
- Acronym / sponsor ID
- BC_EP
- Conditions
- Breast Cancer, Old Age
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
Breast cancer is one of the tumors with the highest incidence and current evidence indicates a higher prevalence in elderly patients (≥70 years) with a higher mortality rate due to immunosenescence, diagnostic delay and under treatment. Elderly patients are still poorly represented in clinical trials and the main indications for the treatment of the elderly population are extrapolated from the guidelines used in studies conducted predominantly on the younger population. In particular, these guidelines do not take into account the significant variability of elderly patients, in particular their comorbidities, performance status, physiological age and frailty.
The aim of this study is to improve understanding of the clinical efficacy and safety of CDK 4/6i in older women in a real-world setting compared to younger women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this cross-sectional study includes patients followed at the Medical Oncology Foundation IRCCS Policlinico San Matteo Pavia and Medical Oncology ICS Maugeri Pavia, suffering from solid tumors subjected to active systemic treatment with CDK4/6 for the disease in the adjuvant phase
Key inclusion criteria (2 listed)
- age over 18 years
- patients with solid tumours undergoing active systemic treatment with CDK4/6 for adjuvant disease
Key exclusion criteria (1 listed)
- Patients who are unable to understand informed consent document
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
Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
The primary objective of this study will be to evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during CDK 4/6i administration. The primary endpoint will be the estimated incidence of toxicity (haematological and/or non-haematological) of any grade over a 12-month time window in elderly MBC and EBC patients (≥70 years) from our cohort of cancer patients treated with CDK 4/6i.
4 secondary outcomes
Compare the toxicity rate between elderly and young MBC subjects;
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the rate of switch therapies between elderly and younger EBC subjects;
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the rate of dose reductions between elderly and younger EBC subjects;
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the invasive disease free survival (iDFS) between elderly and younger EBC subjects.
Time frame: from the date of CDK 4/6i initiation to the date of first occurrence of ipsilateral invasive breast tumor recurrence, assessed up to 24 months
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 10 Feb 2026.
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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.
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 and Old Age, run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 2 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i. (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 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 10 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.