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

NCT ID: NCT05051956

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2021-12-15

Brief Summary

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.

Conditions

Can the Geriatric Questionnaires Predict Adverse Effects in Geriatric Breast Cancer Patients Treated With Cyclin-dependent Kinase 4 and 6 Inhibitors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Palbociclib 125mg and Ribociclib 600 mg

Intervention Type: DRUG

Administration of Palbociclib or Ribociclib

Interventions

Palbociclib 125mg and Ribociclib 600 mg

Administration of Palbociclib or Ribociclib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Below 65 years old

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Namik Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Asoc. Prof. Erdoğan Selçuk Şeber

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birol Ocak, MD

Role: PRINCIPAL_INVESTIGATOR

Uludag University

Özlem Aydın İsak, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara Dışkapı Yıldırım Beyazıd Training and Research Hospital

Elif Şenocak Taşçı, MD

Role: PRINCIPAL_INVESTIGATOR

Mehmet Ali Aydınlar Acıbadem University

Seher Yıldız Tacar, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Sadi Konuk Bakırköy Training and Research Hospital

Müslih Ürün, MD

Role: PRINCIPAL_INVESTIGATOR

Eskişehir City Hospital

Sema Türker, MD

Role: PRINCIPAL_INVESTIGATOR

Zonguldak Atatürk Public Hospital

Turgut Kaçan, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Bursa Yüksek İhtisas Training and Research Hospital

Özlem Özdemir, MD

Role: PRINCIPAL_INVESTIGATOR

İzmir Bozyaka Training and Research Hospital

Eda Tanrıkulu Şimşek, MD

Role: PRINCIPAL_INVESTIGATOR

Haydarpaşa Numune Training and Research Hospital

Hasan Çağrı Yıldırım, MD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Teoman Şakalar, MD

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaraş Necip Fazıl City Hospital

Gülhan İpek Deniz, MD

Role: PRINCIPAL_INVESTIGATOR

Private Tansan Clinic

Mustafa Ersoy, MD

Role: PRINCIPAL_INVESTIGATOR

Eskişehir Osmangazi University

Yusuf Karakaş, MD

Role: PRINCIPAL_INVESTIGATOR

Acıbadem Bodrum Hospital

Ezgi Değerli, MD

Role: PRINCIPAL_INVESTIGATOR

İstanbul University Cerrahpaşa Medicine Faculty

Hacer Demir, MD

Role: PRINCIPAL_INVESTIGATOR

Afyon University of Health Sciences

Sinem Akbaş, MD

Role: PRINCIPAL_INVESTIGATOR

Koç University Hospital

Ahmet Gülmez, MD

Role: PRINCIPAL_INVESTIGATOR

İnönü University

Özkan Alan, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Tekirdağ Fehmi Cumalıoğlu City Hospital

Rukiye Arıkan, MD

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Özden Özer, MD

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Sercan Ön, MD

Role: PRINCIPAL_INVESTIGATOR

Ege University

Zahid Koçak, MD

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Nil Molinas Mandel, Prof.

Role: PRINCIPAL_INVESTIGATOR

Koç University

Onur Eşbah, Prof.

Role: PRINCIPAL_INVESTIGATOR

Duzce University

Ali İnal, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Mersin City Hospital

Murat Araz, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Halil Taşkaynatan, MD

Role: PRINCIPAL_INVESTIGATOR

İzmir Private Ege City Hospital

Abdullah Sakin, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yıl University

Eyyüp Çavdar, MD

Role: PRINCIPAL_INVESTIGATOR

Namik Kemal University

Kubilay Karaboyun, MD

Role: PRINCIPAL_INVESTIGATOR

Namik Kemal University

Erdoğan Selçuk Şeber, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Namik Kemal University

Locations

Tekirdağ Namık Kemal University

Tekirdağ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Okan AVCI, MD

Role: CONTACT

drokanavci@gmail.com

05302073000

Yakup İriağaç, MD

Role: CONTACT

yakupiriagac@hotmail.com

+905321579248

Facility Contacts

Okan AVCI, MD

Role: primary

drokanavci@gmail.com

Other Identifiers

Geriatric-CDK4/6

Identifier Type: -

Identifier Source: org_study_id