Clinical trial · Observational
Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
NCT06558084CI-TRIAL-00079880completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Progression, Disease | — | UNRESOLVED | — |
| Toxicity, Drug | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDK4/6 Inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic breast cancer patients
- description
- metastatic breast cancer patient receiving CDK4/6i in 1st or 2nd line
- interventionNames
- Drug: CDK4/6 Inhibitor
Primary outcomes (1)
- measure
- Adverse effect
- timeFrame
- 2 years
- description
- assess the toxicity profile
Secondary outcomes (1)
- measure
- PFS
- timeFrame
- 2 years
- description
- PFS in patient receiving CDK4/6i in Egypt
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.