Evaluation of Geriatric Questionnaires to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?

Evaluation of the G8 Questionnaire and the Groningen Frailty Indicator to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?

CDK 4/6 inhibitors (palbociclib, ribociclib) have taken their place in our practice recently with their clinical benefits in the treatment of hormone-positive and HER2 negative metastatic breast cancer. Abemaciclib, another CDK 4/6 inhibitor, is not frequently preferred because of reimbursement problems in Turkey. The most obvious advantages of CDK 4/6 inhibitors are that they are used orally and have relatively fewer side effects against chemotherapy. Neutropenia, diarrhea, elevation in liver function tests are the main dose-limiting side effects. In the geriatric age group, it can be thought that the expected benefit from the treatment will not be achieved in cases where these side effects cannot be predicted or managed well. The geriatric age group (65 years and older) deserves special attention in oncology practice, considering both the treatments and the disease itself. Although a number of very useful clinical scales have been developed regarding this subject, it is important that the scale used should be comprehensive as well as being easily applicable for integrating it into daily practice. Geriatric 8 (G8) was found to be a highly sensitive test based on a comprehensive geriatric examination, while the Groningen frailty scale with high specificity. The common feature of these two tests is that they are suitable for daily practice as they are easy to fill. In the light of this information, we aimed to examine whether the G8 and Groningen frailty scale could shed light on clinicians in predicting side effects during the use of CDK 4/6 inhibitors (palbociclib and ribociclib) in geriatric breast cancer patients. We also aimed to reveal the adverse events of these CDK 4/6 inhibitors as real-life experience.

Study Overview

• Status: Not yet recruiting
• Conditions: Can the Geriatric Questionnaires Predict Adverse Effects in Geriatric Breast Cancer Patients Treated With Cyclin-dependent Kinase 4 and 6 Inhibitors
• Intervention / Treatment: Drug: Palbociclib 125mg and Ribociclib 600 mg

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Okan AVCI, MD; Phone Number: 05302073000; Email: drokanavci@gmail.com
• Study Contact Backup: Name: Yakup İriağaç, MD; Phone Number: +905321579248; Email: yakupiriagac@hotmail.com

Study Locations

• Turkey
  • Tekirdağ, Turkey
    • Tekirdag Namık Kemal University
    • Contact: Okan AVCI, MD; Email: drokanavci@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Geriatric (65 years and older) breast cancer patients treated with CDK4/6 inhibitors (Palbociclib or Ribociclib)

Description

Inclusion Criteria:

• Breast cancer 65 years and older Treated with CDK 4/6 inhibitors (Palbociclib or Ribociclib)

Exclusion Criteria:

• Below 65 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CDK4/6 inhibitors; The patient who is started on one of the CDK 4/6 inhibitors (palbociclib 125 mg 3 weeks on 1 week off) or ribociclib 600 mg 3 weeks on 1 week off) will be followed up for adverse events.	Drug: Palbociclib 125mg and Ribociclib 600 mg; Administration of Palbociclib or Ribociclib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	First and second adverse events	6 months period

Collaborators and Investigators

• Sponsor: Namik Kemal University
• Investigators: Principal Investigator: Birol Ocak, MD, Uludag University; Principal Investigator: Özlem Aydın İsak, MD, Ankara Dışkapı Yıldırım Beyazıd Training and Research Hospital; Principal Investigator: Elif Şenocak Taşçı, MD, Mehmet Ali Aydınlar Acıbadem University; Principal Investigator: Seher Yıldız Tacar, MD, Dr. Sadi Konuk Bakırköy Training and Research Hospital; Principal Investigator: Müslih Ürün, MD, Eskişehir City Hospital; Principal Investigator: Sema Türker, MD, Zonguldak Atatürk Public Hospital; Principal Investigator: Turgut Kaçan, Assoc. Prof, Bursa Yuksek Ihtisas Training and Research Hospital; Principal Investigator: Özlem Özdemir, MD, Izmir Bozyaka Training and Research Hospital; Principal Investigator: Eda Tanrıkulu Şimşek, MD, Haydarpasa Numune Training and Research Hospital; Principal Investigator: Hasan Çağrı Yıldırım, MD, Hacettepe University; Principal Investigator: Teoman Şakalar, MD, Kahramanmaraş Necip Fazıl City Hospital; Principal Investigator: Gülhan İpek Deniz, MD, Private Tansan Clinic; Principal Investigator: Mustafa Ersoy, MD, Eskisehir Osmangazi University; Principal Investigator: Yusuf Karakaş, MD, Acıbadem Bodrum Hospital; Principal Investigator: Ezgi Değerli, MD, İstanbul University Cerrahpaşa Medicine Faculty; Principal Investigator: Hacer Demir, MD, Afyon University of Health Sciences; Principal Investigator: Sinem Akbaş, MD, Koc University Hospital; Principal Investigator: Ahmet Gülmez, MD, Inonu University; Principal Investigator: Özkan Alan, Assoc. Prof., Tekirdağ Fehmi Cumalıoğlu City Hospital; Principal Investigator: Rukiye Arıkan, MD, Marmara University; Principal Investigator: Özden Özer, MD, Dokuz Eylül University; Principal Investigator: Sercan Ön, MD, Ege University; Principal Investigator: Zahid Koçak, MD, Necmettin Erbakan University; Principal Investigator: Nil Molinas Mandel, Prof., Koc University; Principal Investigator: Onur Eşbah, Prof., Duzce University; Principal Investigator: Ali İnal, Assoc. Prof., Mersin City Hospital; Principal Investigator: Murat Araz, Assoc. Prof., Necmettin Erbakan University; Principal Investigator: Halil Taşkaynatan, MD, İzmir Private Ege City Hospital; Principal Investigator: Abdullah Sakin, Assoc. Prof., Yuzuncu Yıl University; Principal Investigator: Eyyüp Çavdar, MD, Tekirdag Namık Kemal University; Principal Investigator: Kubilay Karaboyun, MD, Tekirdag Namık Kemal University; Principal Investigator: Erdoğan Selçuk Şeber, Assoc. Prof., Tekirdag Namık Kemal University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 15, 2021

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (ACTUAL): September 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Palbociclib
• Other Study ID Numbers: Geriatric-CDK4/6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No