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

NCT07273357 | Not Yet Recruiting

• 1 other identifier: EPM 2025-06207-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

Brief 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

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

Keywords

Older patients; Geriatric screening; Adjuvant CDK4/6 inhibitors; Breast cancer

Outcome Measures

Primary Outcomes (2)

• Frailty as assessed by Geriatric 8 (G8)

  Geriatric 8 (G8) geriatric screening. 8 questions. Generating total score (0-17). ≤14 indicates frailty.

  Baseline

• 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.

  Baseline

Secondary Outcomes (10)

• Global health status and Quality of Life (QoL) (GHS)

  Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation.

• Summary score

  Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation

• Ten scales

  Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation.

• Adverse events

  At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6i initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).

• Hospitalization

  At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6inhibitor (CDK4/6i) initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).

Study Arms (1)

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• ≥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

You may not qualify if:

• Impaired cognitive function not able to understand the study intention or perform questionaries
• Declining adjuvant CDK4/6i

Sponsors & Collaborators

• Region Örebro County: collaborator
• Region Östergötland: collaborator
• Region Gävleborg: collaborator
• Västra Götalandsregionen: collaborator
• Linkoeping University: collaborator
• Region Jönköping County: lead
• Örebro University, Sweden: collaborator
• Kalmar County Hospital: collaborator

Study Sites (6)

Department of Oncology

Gävle, Sweden

Location

Department of Oncology

Gothenburg, Sweden

Location

Department of Oncology

Jönköping, 55312, Sweden

Location

Department of Oncology

Kalmar, Sweden

Location

Department of Oncology

Linköping, Sweden

Location

Department of Oncology

Örebro, Sweden

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christine Lundgren, MD

  Department of Oncology, Jönköping, Region Jönköping County, Jönköping; Sweden,

  STUDY CHAIR

Central Study Contacts

Christine Lundgren, MD

CONTACT

+46102422907; christine.lundgren@rjl.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 9, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): August 1, 2039
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

SE (6)