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

NCT05670054 | Unknown Phase 3

• 1 other identifier: MD.22.07.674
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Stage IV

Outcome Measures

Primary Outcomes (3)

• The rate of objective response and clinical benefit

  compare objective response rate and clinical benefit rate between the 2 arms

  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

  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

  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

Study Arms (2)

palbociclib + fulvestrant

ACTIVE COMPARATOR

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

Ribociclib + fulvestrant

ACTIVE COMPARATOR

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

Interventions

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

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

Ribociclib + fulvestrant; palbociclib + fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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).
• nd malignancy other than breast cancer
• ECOG more than 3

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncology center mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Quality of Life; Progression-Free Survival

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Treatment Outcome; Prognosis; Diagnosis; Survival Analysis; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• manar hamed, MD

  Oncology center mansoura university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

manar hamed, MD

CONTACT

+201063678209; manarhamed@mans.edu.eg

Ahmed tantawy, MD

CONTACT

01091203484; hamedmanar9@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer medical oncology

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: January 4, 2023
• Study Start: March 1, 2022
• Primary Completion: October 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: at january 2023 for 3 years
• Access Criteria: All data will be available to the fellow researchers

Locations

EG (1)