Development of a New Remote Monitoring Model for Patients With HR+HER2- Breast Cancer in Treatment With CDK4/6 Inhibitors and Hormone Therapy

Not yet recruiting

• Conditions: Breast Cancer; CDK4/6 Inhibitor

• Registration Number: NCT07190651
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 patients' quality of life and reduce burden of hospital accesses.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2025-10-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance between the results of the questionnaire and the clinical examination of the patients.	12 months	This study will validate a questionnaire to select patients who need to access to hospital for clinical visit during treatment with CDK4/6i + hormone therapy for advanced breast cancer. Concordance between the results of the questionnaire (3 flags) and the clinical examination of the patients will be evaluated.