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Recruiting NCT06044623

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

Phase III Interventional Metastatic Breast Cancer Advanced Breast Cancer Quality of Life Toxicity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CDK 4/6 inhibitors, Endocrine therapy.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer, Advanced Breast Cancer, Quality of Life, Toxicity. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland, Greece, Italy, Norway, Spain +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Implementing Geriatric Assessment for Dose Optimization of CDK 4/6-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial (IMPORTANT Trial)

Overview

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.

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

Primary outcome measures

  • Time to treatment failure [Time frame: Up to 5 years from treatment initiation]
Secondary outcome measures (8)
  • Overall treatment utility (OTU) [Time frame: Three months after treatment initiation]
  • Overall survival [Time frame: Up to 5 years from treatment initiation]
  • Progression free survival [Time frame: Up to 5 years from treatment initiation]
  • Time to chemotherapy initiation [Time frame: Up to 5 years from treatment initiation]
  • Frequency of adverse events [Time frame: Up to 5 years from treatment initiation]
  • Assessment of Quality of life [Time frame: Until disease progression, participant / physician decision to stop, death, or up to 24 months from treatment initiation whichever occurs first]
  • Time until Quality of life deterioration [Time frame: Until disease progression, participant / physician decision to stop, death, or up to 24 months from treatment initiation whichever occurs first]
  • Cost effectiveness [Time frame: Up to 24 months from treatment initiation]

Eligibility criteria

Inclusion 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 analysis of the most recent tumor specimen by local laboratory.
  • Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.
  • No prior systemic treatment for advanced disease (recurrence during neo-/adjuvant endocrine therapy is allowed). A prior period of treatment with aromatase inhibitors or fulvestrant for up to 28 days from the CDK 4/6-inhibitor initiation is allowed.
  • Adjuvant treatment with CDK 4/6-inhibitors is allowed provided a disease-free interval from treatment end >12 months.
  • Either measurable disease or non-measurable bone only disease, but evaluable according to RECIST criteria 1.1.
  • Written informed consent prior to any study-specific procedures.
  • Adequate organ function as defined in the summary of product characteristics (SmPC) for the CDK 4/6-inhibitors that is planned to be used.
  • Able to swallow capsules.
  • Able to understand and consent in English language or in native language for each participating country.

Exclusion criteria

Eligible patients will be excluded if they have one of the following criteria:

  • Patients considered from treating physician as non-suitable for treatment with CDK 4/6-inhibitors.
  • Contraindications according to SmPC for the CDK 4/6-inhibitors that is planned to be used.
  • Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningeal carcinomatosis.
  • History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
  • Participating in other interventional trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Greece · 5 centers
  • Fourth Oncology Department & Comprehensive Clinical Trials Center, Metropolitan Hospital — Athens
  • Second Department of Medical Oncology, Hygeia Hospital — Athens
  • Division of Oncology, Department of Medicine, University Hospital, University of Patras Me — Pátrai
  • Medical Oncology Unit, S. Andrew Hospital — Pátrai
  • Second Department of Medical Oncology, Euromedica General Clinic — Thessaloniki
Italy · 2 centers
  • Radiation Oncology Unit - Oncology Department, Azienda Ospedaliero Universitaria Careggi — Florence
  • "Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato — Prato
Sweden · 2 centers
  • Department of Oncology, Örebro University Hospital — Örebro
  • Department of Oncology, Uppsala University Hospital — Uppsala
Finland · 1 center
  • Department of Oncology, Helsinki University Hospital Comprehensive Cancer Center and Unive — Helsinki
Norway · 1 center
  • Department of Oncology, Akershus University Hospital (AHUS) — Oslo
Spain · 1 center
  • Department of Medical Oncology, Hospital Clinic of Barcelona — Barcelona

Publications

  • Valachis A, Biganzoli L, Christopoulou A, Fjermeros K, Fountzila E, Geisler J, Gomez-Bravo R, Karihtala P, Kosmidis P, Koutras A, Linardou H, Lindman H, Martinez-Ballestero I, Rodriguez AB, Meattini I, Munoz-Mateu M, Othman M, Psyrri A, Risi E, Schiza A, Spathas N, Utriainen M, Visani L, Ballesteros S, Basdekis I, Hay SD, Fotis T, Fricker S, de Graaf G, Jenset M, Kanters T, Lampropoulos K, Markou PMID 39431459

Identifiers

NCT: NCT06044623 · 280232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗