Clinical trial NCT05051956: Evaluation of Geriatric Questionnaires to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?
Official title: Evaluation of the G8 Questionnaire and the Groningen Frailty Indicator to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Can the Geriatric Questionnaires Predict Adverse Effects in Geriatric Breast Cancer Patients Treated With Cyclin-dependent Kinase 4 and 6 Inhibitors
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 140
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Geriatric (65 years and older) breast cancer patients treated with CDK4/6 inhibitors (Palbociclib or Ribociclib)

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.


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

Primary outcomes:
measure: Adverse Event
timeFrame: 6 months period
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Tekirdağ Namık Kemal University
Study officials:
affiliation: Uludag University
name: Birol Ocak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Dışkapı Yıldırım Beyazıd Training and Research Hospital
name: Özlem Aydın İsak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mehmet Ali Aydınlar Acıbadem University
name: Elif Şenocak Taşçı, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Sadi Konuk Bakırköy Training and Research Hospital
name: Seher Yıldız Tacar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eskişehir City Hospital
name: Müslih Ürün, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zonguldak Atatürk Public Hospital
name: Sema Türker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bursa Yüksek İhtisas Training and Research Hospital
name: Turgut Kaçan, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: İzmir Bozyaka Training and Research Hospital
name: Özlem Özdemir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haydarpaşa Numune Training and Research Hospital
name: Eda Tanrıkulu Şimşek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Hasan Çağrı Yıldırım, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kahramanmaraş Necip Fazıl City Hospital
name: Teoman Şakalar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Tansan Clinic
name: Gülhan İpek Deniz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eskişehir Osmangazi University
name: Mustafa Ersoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Acıbadem Bodrum Hospital
name: Yusuf Karakaş, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: İstanbul University Cerrahpaşa Medicine Faculty
name: Ezgi Değerli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyon University of Health Sciences
name: Hacer Demir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Koç University Hospital
name: Sinem Akbaş, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: İnönü University
name: Ahmet Gülmez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tekirdağ Fehmi Cumalıoğlu City Hospital
name: Özkan Alan, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Rukiye Arıkan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Özden Özer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Sercan Ön, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: Zahid Koçak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Koç University
name: Nil Molinas Mandel, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duzce University
name: Onur Eşbah, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin City Hospital
name: Ali İnal, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: Murat Araz, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: İzmir Private Ege City Hospital
name: Halil Taşkaynatan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuzuncu Yıl University
name: Abdullah Sakin, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Namik Kemal University
name: Eyyüp Çavdar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Namik Kemal University
name: Kubilay Karaboyun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Namik Kemal University
name: Erdoğan Selçuk Şeber, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: