Status:
COMPLETED
Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
Lead Sponsor:
Ain Shams University
Conditions:
Toxicity, Drug
Progression, Disease
Eligibility:
FEMALE
18+ years
Brief Summary
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population
Eligibility Criteria
Inclusion
- Breast cancer patients aged 18 years old or more
- Female patients
- Histologically proven invasive breast cancer
- Histologically proven HR-positive and HER2-negative breast cancer
- Metastatic breast cancer (Stage 4 according to AJCC 8th edition 2017)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 3.
- Adequate hematological and organs function
- Patients receiving CDK 4/6 inhibitor combined with endocrine therapy(Aromatase inhibitors , GnRH agonists, fulvastrent). as a first or second line treatment
Exclusion
- \- Male breast cancer patients
- Patients in, visceral crisis (defined as : severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease ) that are at risk of life threatening complication in the short term.
- Prior treatment with any CDK 4/6 inhibitor.
- History of any other cancer , unless in complete remission with no therapy for a minimum of 3 years.
- Have active bacterial or fungal infection, or detectable viral infection.
Key Trial Info
Start Date :
July 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 10 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06558084
Start Date
July 6 2022
End Date
August 10 2024
Last Update
August 16 2024
Active Locations (1)
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1
Ainshams University
Cairo, Egypt