Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib 125mg and Ribociclib 600 mg | Drug | Administration of Palbociclib or Ribociclib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | First and second adverse events | 6 months period |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Geriatric (65 years and older) breast cancer patients treated with CDK4/6 inhibitors (Palbociclib or Ribociclib)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Okan AVCI, MD | Contact | 05302073000 | drokanavci@gmail.com | |
| Yakup İriağaç, MD | Contact | +905321579248 | yakupiriagac@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Birol Ocak, MD | Uludag University | Principal Investigator |
| Özlem Aydın İsak, MD | Ankara Dışkapı Yıldırım Beyazıd Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tekirdağ Namık Kemal University | Tekirdağ | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 Yüksek İhtisas Training and Research Hospital | Principal Investigator |
| Özlem Özdemir, MD | İzmir Bozyaka Training and Research Hospital | Principal Investigator |
| Eda Tanrıkulu Şimşek, MD | Haydarpaşa 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 | Eskişehir 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 | İnönü 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 Eylul University | Principal Investigator |
| Sercan Ön, MD | Ege University | Principal Investigator |
| Zahid Koçak, MD | Necmettin Erbakan University | Principal Investigator |
| Nil Molinas Mandel, Prof. | Koç 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 Yil University | Principal Investigator |
| Eyyüp Çavdar, MD | Namik Kemal University | Principal Investigator |
| Kubilay Karaboyun, MD | Namik Kemal University | Principal Investigator |
| Erdoğan Selçuk Şeber, Assoc. Prof. | Namik Kemal University | Principal Investigator |
| ID | Term |
|---|---|
| C500026 | palbociclib |
| C000589651 | ribociclib |
Not provided
Not provided
Not provided