Status:
NOT_YET_RECRUITING
Development of a New Remote Monitoring Model for Patients With HR+HER2- Breast Cancer in Treatment With CDK4/6 Inhibitors and Hormone Therapy
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Breast Cancer
CDK4/6 Inhibitor
Eligibility:
FEMALE
18+ years
Brief Summary
This study aims to develop and prospectively validate a questionnaire to select patients with breast cancer who need to access to hospital for clinical visit during treatment with CDK4/6i, to improve ...
Eligibility Criteria
Inclusion
- Written informed consent.
- Age ≥18 years old
- Histologically or cytologically documented diagnosis of HR+, HER2-negative breast cancer based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent. HR+ tumor is defined as ER and/or PgR expression in greater than 1% of tumor cells. HER2-negative breast cancer is defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory).
- Currently on treatment and have received ≥ 2 months of CDK4/6i + hormone therapy as their initial endocrine based treatment for their metastatic disease in concordance with local CDK4/6i label or treatment guideline.
- No evidence of clinical or radiological disease progression per investigator assessment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
Exclusion
- History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
- Patient has a concurrent invasive malignancy and /or is concurrently using other anti-neoplastic therapy.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07190651
Start Date
October 1 2025
End Date
September 30 2026
Last Update
September 24 2025
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