Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 5:21 AM
Study NCT ID:
NCT05051956
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Geriatric Questionnaires to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}, {'id': 'C000589651', 'term': 'ribociclib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-15', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event', 'timeFrame': '6 months period', 'description': 'First and second adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Can the Geriatric Questionnaires Predict Adverse Effects in Geriatric Breast Cancer Patients Treated With Cyclin-dependent Kinase 4 and 6 Inhibitors']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Geriatric (65 years and older) breast cancer patients treated with CDK4/6 inhibitors (Palbociclib or Ribociclib)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer 65 years and older Treated with CDK 4/6 inhibitors (Palbociclib or Ribociclib)\n\nExclusion Criteria:\n\n* Below 65 years old'}, 'identificationModule': {'nctId': 'NCT05051956', 'briefTitle': 'Evaluation of Geriatric Questionnaires to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'Evaluation of the G8 Questionnaire and the Groningen Frailty Indicator to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?', 'orgStudyIdInfo': {'id': 'Geriatric-CDK4/6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CDK4/6 inhibitors', 'description': '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.', 'interventionNames': ['Drug: Palbociclib 125mg and Ribociclib 600 mg']}], 'interventions': [{'name': 'Palbociclib 125mg and Ribociclib 600 mg', 'type': 'DRUG', 'description': 'Administration of Palbociclib or Ribociclib', 'armGroupLabels': ['CDK4/6 inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tekirdağ', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Okan AVCI, MD', 'role': 'CONTACT', 'email': 'drokanavci@gmail.com'}], 'facility': 'Tekirdağ Namık Kemal University', 'geoPoint': {'lat': 40.9781, 'lon': 27.51101}}], 'centralContacts': [{'name': 'Okan AVCI, MD', 'role': 'CONTACT', 'email': 'drokanavci@gmail.com', 'phone': '05302073000'}, {'name': 'Yakup İriağaç, MD', 'role': 'CONTACT', 'email': 'yakupiriagac@hotmail.com', 'phone': '+905321579248'}], 'overallOfficials': [{'name': 'Birol Ocak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uludag University'}, {'name': 'Özlem Aydın İsak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Dışkapı Yıldırım Beyazıd Training and Research Hospital'}, {'name': 'Elif Şenocak Taşçı, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mehmet Ali Aydınlar Acıbadem University'}, {'name': 'Seher Yıldız Tacar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Sadi Konuk Bakırköy Training and Research Hospital'}, {'name': 'Müslih Ürün, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eskişehir City Hospital'}, {'name': 'Sema Türker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zonguldak Atatürk Public Hospital'}, {'name': 'Turgut Kaçan, Assoc. Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yüksek İhtisas Training and Research Hospital'}, {'name': 'Özlem Özdemir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İzmir Bozyaka Training and Research Hospital'}, {'name': 'Eda Tanrıkulu Şimşek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haydarpaşa Numune Training and Research Hospital'}, {'name': 'Hasan Çağrı Yıldırım, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Teoman Şakalar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kahramanmaraş Necip Fazıl City Hospital'}, {'name': 'Gülhan İpek Deniz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Private Tansan Clinic'}, {'name': 'Mustafa Ersoy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eskişehir Osmangazi University'}, {'name': 'Yusuf Karakaş, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acıbadem Bodrum Hospital'}, {'name': 'Ezgi Değerli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İstanbul University Cerrahpaşa Medicine Faculty'}, {'name': 'Hacer Demir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Afyon University of Health Sciences'}, {'name': 'Sinem Akbaş, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Koç University Hospital'}, {'name': 'Ahmet Gülmez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İnönü University'}, {'name': 'Özkan Alan, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tekirdağ Fehmi Cumalıoğlu City Hospital'}, {'name': 'Rukiye Arıkan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University'}, {'name': 'Özden Özer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylul University'}, {'name': 'Sercan Ön, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University'}, {'name': 'Zahid Koçak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necmettin Erbakan University'}, {'name': 'Nil Molinas Mandel, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Koç University'}, {'name': 'Onur Eşbah, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duzce University'}, {'name': 'Ali İnal, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mersin City Hospital'}, {'name': 'Murat Araz, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necmettin Erbakan University'}, {'name': 'Halil Taşkaynatan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İzmir Private Ege City Hospital'}, {'name': 'Abdullah Sakin, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil 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', 'affiliation': 'Namik Kemal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namik Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Asoc. Prof. Erdoğan Selçuk Şeber', 'investigatorAffiliation': 'Namik Kemal University'}}}}