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Follow-Up After adjuvanT CDK4/6i Use in oldeR brEast Cancer Patients - Aspects on Geriatric Screening, Toxicities, and Quality of Life (FUTURE)

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• ≥70 years old

• Female/male

• Completed surgery (primary or after neoadjuvant therapy)

• Starting adjuvant CDK4/6i and endocrine therapy

• Cognitive performance to be able answer questionaries

• No language difficulties

Locations
Other Locations
Sweden
Department of Oncology
RECRUITING
Gävle
Department of Oncology
RECRUITING
Jönköping
Department of Oncology
RECRUITING
Kalmar
Department of Oncology
RECRUITING
Linköping
Department of Oncology
NOT_YET_RECRUITING
Örebro
Contact Information
Primary
Christine Lundgren, MD
christine.lundgren@rjl.se
+46102422907
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2039-08-01
Participants
Target number of participants: 200
Treatments
Frail and fit older (≥70 years) breast cancer patients
Older (≥70 years) patients, with early stage breast cancer, initiating adjuvant CDK4/6 inhibitors that are defined as frail or fit according to G8 and VES-13
Related Therapeutic Areas
Sponsors
Collaborators: Linkoeping University, Kalmar County Hospital, Region Örebro County, Västra Götalandsregionen, Region Gävleborg, Region Östergötland, Örebro University, Sweden
Leads: Region Jönköping County

This content was sourced from clinicaltrials.gov

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