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Trial Title:
Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer Patients
NCT ID:
NCT05670054
Condition:
Breast Cancer Stage IV
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival
Description:
comparing both arms as regard the objective response rate, toxicity profile, quality of
life, progression free survival
Arm group label:
Ribociclib + fulvestrant
Arm group label:
palbociclib + fulvestrant
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
- Pathologically proven diagnosis of adenocarcinoma of the breast with evidence
of metastatic disease either progression on adjuvant hormonal or progression on
1st line hormonal for metastatic disease.
- Documentation of ER-positive and/or PR-positive and HER2 negative.
- Prior use of endocrine therapy.
- age >18 years old.
- ECOG: 0-2
- Postmenopausal is defined as: age>60 years old or < 60 years old with cessation off
menstruation for at least 12 months and FSH or E2 in postmenopausal range or
patients who underwent bilateral oophorectomy.
- Premenopausal is defined if not meeting the criteria of postmenopausal. They are
obligated to receive LHRH agonist with their treatment.
Exclusion Criteria:
-
- Age < 18 years old
- Patients with advanced/metastatic, symptomatic, visceral spread(visceral crisis) ,
that are at risk of life-threatening complications in the short term (including
patients with massive uncontrolled effusions [pleural, pericardial, peritoneal],
pulmonary lymphangitis, and over 50% liver involvement).
- 2nd malignancy other than breast cancer
- ECOG more than 3
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology center mansoura university
Address:
City:
Mansoura
Zip:
35516
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
manar hamed, MD
Phone:
01063678209
Email:
manarhamed@mans.edu.eg
Contact backup:
Last name:
ahmed tantawy, MD
Phone:
01091203484
Email:
hamedmanar9@gmail.com
Start date:
March 1, 2022
Completion date:
December 15, 2023
Lead sponsor:
Agency:
Mansoura University
Agency class:
Other
Source:
Mansoura University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05670054
