Breast Cancer, CDK4/6 Inhibitor
Conditions
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.
Interventions
OTHERHome 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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactIDA PARIS
Outcome results
None listed