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

NCT07190651 | Not Yet Recruiting

• 1 other identifier: ID 7960
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Concordance between the results of the questionnaire and the clinical examination of the patients.

  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.

  12 months

Study Arms (1)

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.

Other: Home questionnaire

Interventions

Home questionnaire 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

IDA PARIS

CONTACT

+39 06 30151; senogin@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share