Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
NCT ID: NCT06558084
Last Updated: 2024-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
64 participants
OBSERVATIONAL
2022-07-06
2024-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Metastatic breast cancer patients
metastatic breast cancer patient receiving CDK4/6i in 1st or 2nd line
CDK4/6 Inhibitor
CDK4/6 inhibitor in first and second lines
Interventions
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CDK4/6 Inhibitor
CDK4/6 inhibitor in first and second lines
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Asmaa Ali
Assistant lecturer
Locations
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Ainshams University
Cairo, , Egypt
Countries
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Other Identifiers
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CDKTOX2024
Identifier Type: -
Identifier Source: org_study_id
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