Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients

IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach i

Trial Details

NCT ID

NCT06044623

Phase

PHASE3

Sponsor

Region Örebro County

Status

RECRUITING

Cancer Type

ER/PR Positive (Hormone Receptor Positive) Breast Cancer

Interventions

CDK 4/6 inhibitors
Endocrine therapy

Locations (sample)

Helsinki, Finland|60.16952,24.93545
Athens, Greece|37.98376,23.72784
Athens, Greece|37.98376,23.72784
Pátrai, Greece|38.2462,21.73508
Pátrai, Greece|38.2462,21.73508

Key Eligibility Criteria

The following inclusion criteria will be applied:
Patients male or female aged at least 70 years old at the time of informed consent.
Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to an…
Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.

For full eligibility, visit ClinicalTrials.gov.

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