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Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence.

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Grenoble
NCT07443774 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Hormone receptor-positive (HR+) breast cancers represent the most common histological subtype of breast cancer, accounting for approximately 75% of cases, regardless of HER2 (human epidermal growth factor receptor 2) status (1). Adjuvant endocrine therapy (ET), including tamoxifen and aromatase inhibitors (AIs), is an effective pharmacological treatment for improving the prognosis of HR+ breast cancer, reducing the risk of recurrence by up to 50% (2-3-4-6). Despite its proven prognostic benefit, the full potential of endocrine therapy is not realized due to patient non-adherence (i.e., failure to comply with prescribed treatment). Adjuvant endocrine therapy is generally prescribed for a duration of 5 to 10 years. However, up to 40% of patients discontinue treatment prematurely, and 30% take the medication less frequently than prescribed. Poor adherence and low treatment persistence carry

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📋 Eligibility rules (as published)
Inclusion Criteria * Male or female patients aged ≥18 years. * Operable invasive breast carcinoma of no special type, hormone receptor-positive / HER2-negative (estrogen receptor expression \>10% with or without progesterone receptor expression \>10%; HER2-negative defined as score 0, 1+, or 2+ non-amplified). * M0 disease according to the TNM 2018 classification. * Having undergone curative surgery of the primary breast tumor. * Having received adjuvant radiotherapy, if indicated. * Indication for combined adjuvant endocrine therapy and iCDK4/6 therapy validated during a multidisciplinary tumor board meeting. * Initiation of adjuvant endocrine therapy combined with a CDK4/6 inhibitor between June 2023 and June 2028. * No objection to participation in the study. * Affiliation with the national health insurance system. Non-Inclusion Criteria * Medical, geographical, sociological, psychological, or legal conditions that could prevent the patient from completing the study or from providing informed non-opposition. * Locally advanced, non-operable disease or metastatic disease not amenable to curative-intent treatment
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What it tests

  • Not listed
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Where

1 site
CHU Grenoble Alpes
Grenoble, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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