Toxicity, Drug, Progression, Disease
Conditions
Keywords
Breast cancer, CDK4/6 inhibitor, toxicity, PFS
Brief summary
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population
Interventions
DRUGCDK4/6 Inhibitor
CDK4/6 inhibitor in first and second lines
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* \- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect | 2 years | assess the toxicity profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 years | PFS in patient receiving CDK4/6i in Egypt |
Countries
Egypt
Outcome results
None listed