Adherence to Cell Cycle Inhibitors with Endocrine Therapy in Localized High-Risk ER+ Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with hormone receptor–positive, HER2-negative breast cancer who have had surgery and are starting combined endocrine therapy plus a CDK4/6 inhibitor. It aims to document adherence patterns and persistence with the treatment in real-world settings between 2023 and 2028. Data will be collected from routine clinical practice to understand how often patients take their medications as prescribed and completed treatment courses. The study does not assign treatments but observes how patients adhere to a standard of care that includes adjuvant endocrine therapy plus CDK4/6 inhibition. Results could inform strategies to improve persistence and outcomes in this high-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Grenoble Alpes
  Grenoble, France Recruiting

Study contacts

• Principal investigator: Emmanuelle JACQUET — University Hospital, Grenoble
• Study coordinator: Emmanuelle JACQUET, MD, PhD
• Email: ejacquet1@chu-grenoble.fr
• Phone: 33 0)476765451

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.