TYPER– A Randomized Controlled Study Evaluating the Effectiveness of Typology-based Coaching on Therapy Management for Patients with HR+ HER2- Early Breast Cancer Under Adjuvant Treatment with Ribociclib

Conditions

Hormone receptor–positive (HRpos)/human epidermal growth factor receptor 2–negative (HER2neg) early breast cancer at risk of recurrence

Brief summary

time to permanent treatment discontinuation of ribociclib therapy

Detailed description

overall persistence rate at 6, 12 and 36 months of adjuvant ribociclib therapy, relapse- and death-free discontinuation rate at 6,12 and 36 months of adjuvant ribociclib therapy, total time of therapy interruptions within 36 months of ribociclib treatment, surveyed by a patient diary, distress and quality of life assessed via the Functional Assessment of Cancer Therapy—Breast (FACT-B), the EQ-5D/visual analog scale (VAS) questionnaires, and the patient distress thermometer after 3, 6, 9, 12, 24, and 36 months of treatment, frequency of adverse events (AEs) (serious AEs (SAEs) will be reported according to National Cancer Institute (NCI) Common Toxicity Criteria version 5.0), outcomes according to STEEP 2.0 criteria, required health utilities within 12, 24 and 36 months, patient type before coaching and after 12 months of coaching

M. Welslau, Christine Zeder-Goess, Renate Haidinger, B. Welter, B. Aktas et al. (20 authors)

Clinical Cancer Research2026-02-17

10.1158/1557-3265.sabcs25-ps3-08-14

Interventions

DRUGKisqali 200 mg film-coated tablets

DRUGRIBOCICLIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
time to permanent treatment discontinuation of ribociclib therapy	—

Secondary

Measure	Time frame
overall persistence rate at 6, 12 and 36 months of adjuvant ribociclib therapy, relapse- and death-free discontinuation rate at 6,12 and 36 months of adjuvant ribociclib therapy, total time of therapy interruptions within 36 months of ribociclib treatment, surveyed by a patient diary, distress and quality of life assessed via the Functional Assessment of Cancer Therapy—Breast (FACT-B), the EQ-5D/visual analog scale (VAS) questionnaires, and the patient distress thermometer after 3, 6, 9, 12, 24, and 36 months of treatment, frequency of adverse events (AEs) (serious AEs (SAEs) will be reported according to National Cancer Institute (NCI) Common Toxicity Criteria version 5.0), outcomes according to STEEP 2.0 criteria, required health utilities within 12, 24 and 36 months, patient type before coaching and after 12 months of coaching	—

Measure

Time frame

overall persistence rate at 6, 12 and 36 months of adjuvant ribociclib therapy, relapse- and death-free discontinuation rate at 6,12 and 36 months of adjuvant ribociclib therapy, total time of therapy interruptions within 36 months of ribociclib treatment, surveyed by a patient diary, distress and quality of life assessed via the Functional Assessment of Cancer Therapy—Breast (FACT-B), the EQ-5D/visual analog scale (VAS) questionnaires, and the patient distress thermometer after 3, 6, 9, 12, 24, and 36 months of treatment, frequency of adverse events (AEs) (serious AEs (SAEs) will be reported according to National Cancer Institute (NCI) Common Toxicity Criteria version 5.0), outcomes according to STEEP 2.0 criteria, required health utilities within 12, 24 and 36 months, patient type before coaching and after 12 months of coaching

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Countries

Germany

Outcome results

None listed