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

NCT ID: NCT07190651

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-09-30

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.

Conditions

Breast Cancer; CDK4/6 Inhibitor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with advanced HR-positive/Her2-negative Breast Cancer

Women with advanced HR-positive/Her2-negative Breast Cancer (BC) who have completed at least 2 cycles of a first-line therapy with CDK4/6i + hormone therapy and are currently on treatment.

Home questionnaire

Intervention Type: OTHER

Administration of a questionnaire at each 28-days cycle, to select patients who need to access to hospital for clinical visit during treatment with CDK4/6i + hormone therapy for advanced breast cancer.

Interventions

Home questionnaire

Administration of a questionnaire at each 28-days cycle, to select patients who need to access to hospital for clinical visit during treatment with CDK4/6i + hormone therapy for advanced breast cancer.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Paris Ida

Head of Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

IDA PARIS

Role: CONTACT

senogin@policlinicogemelli.it

+39 06 30151

Other Identifiers

ID 7960

Identifier Type: -

Identifier Source: org_study_id