Older breast cancer patients should not be categorically excluded from adjuvant therapies, including the recommended CDK4/6 inhibitors (CDK4/6i) administered in combination with endocrine therapy. Nevertheless, this population frequently presents with comorbidities that may increase susceptibility to treatment-related toxicities, including impacts on quality of life, which must be carefully considered when selecting therapeutic regimens. Given the limited representation of older patients in the clinical trials behind the recommendations for adjuvant CDK4/6i therapy, coupled with the uncertain magnitude of clinical benefit and the reported rates of toxicity and treatment discontinuation, it is essential to critically evaluate both efficacy and safety in this specific patient subgroup. National and international guidelines recommend the integration of geriatric assessments into routine clinical practice to facilitate individualized treatment decisions; however, such assessments are not yet widely implemented in many oncology departments and are not routinely in use to guide adjuvant CDK4/6i therapy.
This study aims to investigate the implementation of geriatric assessments in older breast cancer patients (≥70 years) and to examine multiple dimensions of CDK4/6i treatment in this cohort, including short- and medium-term effects on quality of life, dose intensity, and clinical outcomes. By doing so, the investigators seek to more accurately delineate the benefits and risks of adjuvant CDK4/6i therapy in this specific patient population.
≥70 years old
Female/male
Completed surgery (primary or after neoadjuvant therapy)
Starting adjuvant CDK4/6i and endocrine therapy
Impaired cognitive function not able to understand the study intention or perform questionaries
Declining adjuvant CDK4/6i
All patients with primary breast cancer, regardless of breast cancer subtype, who are ≥70 years old and starting adjuvant CDK4/6i are included in this trial.
Cohort
Prospective
Not listed
Frailty as assessed by Geriatric 8 (G8)
Geriatric 8 (G8) geriatric screening. 8 questions. Generating total score (0-17). ≤14 indicates frailty.
Frailty as assessed by Vulnerable Elders Survey (VES-13)
Vulnerable Elders Survey (VES-13) geriatric screening, 13 questions. Generating total score (0-10). ≥3 indicates frailty.
Global health status and Quality of Life (QoL) (GHS)
Global health status and Quality of Life (QoL) (GHS) comprises the two seven-point Likert scale from the EORTC QLQ-C30 regarding overall health and QoL during the past week.
Summary score
Comprise all questions from the EORTC QLQ-C30 except for those included in the Global health status and Quality of Life (QoL) (GHS) and a question concerning financial difficulties. Scores range from 0 (no Health-related quality of life (HRQOL)) to 100 (the highest HRQoL).
Ten scales
Ten scales include five function scales and five symptom scales from the EORTC-QLQ-C30 and ELD14. Scales included physical, role, and social functioning, fatigue, and pain from the EORTC-QLQ-C30 and maintaining purpose, family support, mobility, future worries, and burden of illness from the EORTC-QLQ ELD14. Scores from all scales range from 0 to 100. High scores for functional scales represent high and healthy functioning, whereas high scores for symptom scales represent high symptomatology.
Adverse events
≥ Grad 3 adverse events (AE) from CDK4/6 inhibitor (CDK4/6i) according to the CTCAE 5.0
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Region Jönköping County
Lead sponsor
Region Örebro County
Collaborator
Region Östergötland
Collaborator
Region Gävleborg
Collaborator
Västra Götalandsregionen
Collaborator
Linkoeping University
Collaborator
Örebro University, Sweden
Collaborator
Kalmar County Hospital
Collaborator
