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Aspects of Adjuvant CDK4/6 Inhibitors in Older Breast Cancer Patients - Focusing on Geriatric Screening

NCT07273357 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-12-09

No results posted yet for this study

Summary

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.

Conditions

  • Geriatric Assessment
  • Adjuvant Drug Therapy
  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Sponsors & Collaborators

  • Region Örebro County

    collaborator OTHER

  • Region Östergötland

    collaborator OTHER

  • Region Gävleborg

    collaborator OTHER

  • Västra Götalandsregionen

    collaborator OTHER

  • Linkoeping University

    collaborator OTHER_GOV

  • Örebro University, Sweden

    collaborator OTHER

  • Kalmar County Hospital

    collaborator OTHER

  • Region Jönköping County

    lead OTHER_GOV

Principal Investigators

  • Christine Lundgren, MD · Department of Oncology, Jönköping, Region Jönköping County, Jönköping; Sweden,

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2029-09-01
Completion
2039-08-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273357 on ClinicalTrials.gov