Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer Patients

NCT ID: NCT05670054

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-12-15

Brief 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.

Conditions

Breast Cancer Stage IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

palbociclib + fulvestrant

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

Group Type: ACTIVE_COMPARATOR

comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival

Intervention Type: DRUG

comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival

Ribociclib + fulvestrant

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

Group Type: ACTIVE_COMPARATOR

comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival

Intervention Type: DRUG

comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Manar Hamed

assistant lecturer medical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

manar hamed, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology center mansoura university

Locations

Oncology center mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

manar hamed, MD

Role: CONTACT

manarhamed@mans.edu.eg

+201063678209

Ahmed tantawy, MD

Role: CONTACT

hamedmanar9@gmail.com

01091203484

Facility Contacts

manar hamed, MD

Role: primary

manarhamed@mans.edu.eg

01063678209

ahmed tantawy, MD

Role: backup

hamedmanar9@gmail.com

01091203484

Other Identifiers

MD.22.07.674

Identifier Type: -

Identifier Source: org_study_id