A Phase 3 interventional study of comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival in Breast Cancer Stage IV, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Mansoura University · Phase 3, Interventional, and Treatment
Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive, HER2 negative advanced breast cancer in the 1st line and subsequent lines in combination with aromatase inhibitors or fulvestrant. Studies showed that they extend progression free survival and recently they showed overall survival benefit. In this study investigators compare Palbociclib+ fulvestrant VS Ribociclib + fulvestrant as a second line treatment in metastatic ER+ve her2 -ve BC in oncology center mansoura university egyptian patients.
Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive, HER2 negative advanced breast cancer in the 1st line and subsequent lines in combination with aromatase inhibitors or fulvestrant. Studies showed that they extend progression free survival and recently they showed overall survival benefit. In this study investigators compare Palbociclib+ fulvestrant VS Ribociclib + fulvestrant as a second line treatment in metastatic ER+ve her2 -ve BC in oncology center mansoura university egyptian patients. The efficacy and comparative toxicity of CDK inhibitors were indirectly compared in a number of trials. Despite differences in inclusion criteria and follow-up length, second-line trials showed similar characteristics.
Unfortunately, despite the similar efficacy and overall response rate (ORR) and a slightly different but near-identical spectrum of adverse events, both agents have not been directly compared with each other. This study aims to fill that gap, and evaluate the toxicity, tolerability and response rate of ribociclib plus fulvestrant versus palbociclib plus fulvestrant, to inform the decision makers.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 116 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Arm A includes patients who receive palbociclib 125 mg tab/day for 3 weeks and 1 week rest+ Fulvestrant 500 mg IM injection d1, d15, d29 1st cycle then every month
Drug: comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival
Arm B includes patients who receive ribociclib 200 mg 3 tabs/day for 3 weeks and 1 week rest+ Fulvestrant 500 mg IM injection d1, d15, d29 1st cycle then every month
Drug: comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival
comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival
The rate of objective response and clinical benefit
compare objective response rate and clinical benefit rate between the 2 arms
Time frame: the last patient recruited in the study will be followed up for at least 6 months
Incidence and grade of toxicity
compare the incidence and grade of toxicity between the 2 arms
Time frame: the last patient recruited in the study will be followed up for at least 6 months
Compare Quality of life score of the patients using EORTC core quality of life questionaire version C-30
compare the level of deterioration of the quality of life score between the 2 arms
Time frame: each patient will answer the QOL score at D0, 3rd and 6 months of treatment as long as he is hasn't progressed on treatment during the 1st 6 months
Plan to share: Yes — the results of the study will be shared and published
Supporting information: Study protocol, Statistical analysis plan
Time frame: at january 2023 for 3 years
Access criteria: All data will be available to the fellow researchers
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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