Standardized Training and Counseling on Treatment Adherence for Patients with Early-Stage Hormone-Receptor-Positive, HER2-Negative Breast Cancer Treated with Abemaciclib

Early-stage breast cancer means that the tumor is confined to the breast and, if present, the nearby lymph nodes in the armpit, and that no metastases have yet formed in other organs (distant metastases). HER2 is a protein on the surface of cells that transmits growth signals into the cell. HER2-negative means that this protein is not detectable on the tumor cells, or is present only in small amounts, and is therefore not present in increased quantities as in HER2-positive tumors. For early-stage hormone receptor-positive breast cancer, anti-hormone therapy (endocrine therapy) is typically administered for several years following surgery; this therapy is intended to deprive the tumor of the effects of the body’s own hormones and thereby reduce the risk of recurrence. Treatment given after surgery is called adjuvant therapy. Patients eligible for this study will receive a combination of anti-hormone therapy and abemaciclib in tablet form (oral). This is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6 inhibitor). Patients typically take oral medications on their own at home. It is known from the medical literature that these medications are not always taken as prescribed. Individual doses may be missed, or treatment may be discontinued earlier than intended (therapeutic adherence and persistence).

Therefore, this study does not evaluate a new medication but rather examines a standardized accompanying training and counseling program (coaching) based on the Oral Agent Teaching Tool (MOATT) developed by the Multinational Association of Supportive Care in Cancer (MASCC). This is a structured tool that healthcare professionals use to educate and counsel people receiving oral cancer therapy. All patients receive this coaching, so there is only one treatment group (uncontrolled) and no random assignment to different groups. The study is open-label (not blinded), which means that both the study physicians and the patients are aware of the intervention. Several questionnaires will be completed to assess treatment adherence.

Eligible participants are women aged 18 and older with early-stage hormone receptor-positive, HER2-negative breast cancer who are receiving abemaciclib in combination with anti-hormone therapy and whose abemaciclib treatment began no more than 28 days ago. Patients who are pregnant or breastfeeding, who have contraindications to taking abemaciclib, or who, from a medical standpoint, have serious comorbidities that preclude participation are not eligible to participate.