Real-World Patient-Reported Outcomes After Initiation of Adjuvant Ribociclib Plus Endocrine Therapy in Early HR+/HER2− Breast Cancer: A Multicentre Prospective Observational Study in Croatia (PRO-QoL-Cro)

Study summary

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Study identification

• EU PAS number:
  EUPAS1000001116
• Study ID:
  1000001116
• Official title and acronym:
  Real-World Patient-Reported Outcomes After Initiation of Adjuvant Ribociclib Plus Endocrine Therapy in Early HR+/HER2− Breast Cancer: A Multicentre Prospective Observational Study in Croatia (PRO-QoL-Cro)
• DARWIN EU® study:
  No
• Study countries:
  Croatia
• Study description:
  PRO-QoL-Cro is a multicentre, prospective, non-interventional, single-arm cohort study with primary data collection at three centres in Croatia: University Hospital Centre Split, University Hospital Centre Osijek and Clinical Hospital Dubrava.; ; The population is adults with HR+/HER2-negative breast cancer, AJCC 8th edition anatomic stage II to III, who initiate adjuvant ribociclib plus endocrine therapy in routine clinical practice, with adjuvant endocrine therapy started within 12 months before baseline. Treatment is prescribed solely according to clinical judgement and the Summary of Product Characteristics. The study does not influence treatment decisions or require study-specific investigations.; ; The overall aim is to generate real-world evidence on patient-reported outcomes, covering health-related quality of life, breast cancer-specific symptoms and functioning, work productivity and informal care needs, during the first six months after initiation of adjuvant ribociclib plus endocrine therapy.; ; The primary objective is to estimate the within-patient change in the EQ-5D-5L utility index from baseline (Month 0) to Month 6. As no Croatian value set exists, scoring uses the Hungarian value set in the primary analysis and the Italian value set in sensitivity analyses.; ; Secondary objectives are to describe changes in EORTC QLQ-BR23 functioning and symptom domains, in work productivity and activity impairment measured with the WPAI:GH, and in informal care needs operationalised as informal care hours per week, and to explore associations of PRO trajectories with treatment-related side effects, sociodemographic characteristics and prior endocrine therapy duration (up to 3 vs 4 to 12 months).; ; Assessments occur at Months 0, 1, 3 and 6. Clinical characteristics, adverse events and treatment modifications are recorded from routine medical records to support interpretation. Of 76 participants to be enrolled, 64 are expected to be evaluable for the primary endpoint.
• Study status:
  Planned

Research institutions and networks

Institutions

University Hospital Centre Split

University Hospital Centre Osijek; Clinical Hospital Dubrava

Study timelines

Date when funding contract was signed

Planned:22/09/2026

Study start date

Planned:28/09/2026

Data analysis start date

Planned:30/11/2027

Date of final study report

Planned:31/03/2028

Sources of funding

Other

More details on funding

Pharmaceutical company and other private sector - Novartis Hrvatska d.o.o.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable