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

Summary

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 in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach.

On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy.

This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.

Conditions

• Metastatic Breast Cancer
• Advanced Breast Cancer
• Quality of Life
• Toxicity
• Older Patients

Interventions

DRUG

CDK 4/6 inhibitors

Either Palbociclib, Ribociclib or Abemaciclib

DRUG

Endocrine therapy

Either Letrozole, Anastrozole, Exemestane or Fulvestrant in combination with CDK 4/6-inhibitor

Sponsors & Collaborators

• University of Patras

  collaborator OTHER

• University of Florence

  collaborator OTHER

• Azienda USL Toscana Centro

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Institute for Medical Technology Assessment - the Netherlands

  collaborator UNKNOWN

• Security Labs Consulting Limited

  collaborator UNKNOWN

• Circular Economy Foundation

  collaborator UNKNOWN

• Universidad Nacional de Educación a Distancia

  collaborator OTHER

• Hellenic Cooperative Oncology Group

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Uppsala County Council, Sweden

  collaborator OTHER_GOV

• Hospital Clinic of Barcelona

  collaborator OTHER

• Phaze Clinical Research & Pharma Consulting

  collaborator UNKNOWN

• Bröstcancerförbundet

  collaborator UNKNOWN

• Eunomia Ltd

  collaborator UNKNOWN

• University of Applied Sciences and Arts Northwestern Switzerland

  collaborator OTHER

• CareAcross

  collaborator INDUSTRY

• Örebro University, Sweden

  collaborator OTHER

• Region Örebro County

  lead OTHER

Principal Investigators

• Antonios Valachis, Assoc Prof · Region Örebro Län

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2028-10-31

Completion

2029-05-31

FDA Drug

Yes

Countries

• Finland
• Greece
• Italy
• Norway
• Spain
• Sweden

Study Locations