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This study is a retrospective review aimed at evaluating the real-world outcomes and clinical efficacy of CDK4/6 inhibitors (such as Palbociclib, Ribociclib, or Abemaciclib) in patients diagnosed with metastatic luminal A and luminal B breast cancer. The study will assess how patients responded to these treatments based on their specific breast cancer subtype (Luminal A vs. Luminal B) by reviewing their medical records.
This is a retrospective, observational cohort study conducted at Sohag University Hospital].
The study will include medical records of female patients diagnosed with metastatic Luminal A and Luminal B breast cancer who received CDK4/6 inhibitors as part of their treatment regimen between 2021 and 2026 Data will be collected regarding Patient demographics and baseline clinical characteristics. Pathological features (Hormone receptor status and Ki-67 levels to differentiate Luminal A and B).
Treatment duration and response rates. Outcomes such as Progression-Free Survival (PFS) and Overall Survival (OS), as well as documented adverse effects.
The primary objective is to compare the clinical outcomes and effectiveness of CDK4/6 inhibitors between the Luminal A and Luminal B metastatic breast cancer subgroups in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| luminal A subgroup | patients diagnosed with metastatic breast cancer |
| |
| luminal B subgroup | patients diagnosed with metastatic breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDK4/6 inhibitors | Drug | Retrospective evaluation of patients who received standard clinical doses of CDK4/6 inhibitors as part of their treatment regimen for metastatic luminal A and luminal B breast cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | Progression-free survival is defined as the time from initiation of CDK4/6 inhibitor therapy until documented disease progression or death from any cause. | Up to 4 years أو From initiation of CDK4/6 inhibitor therapy to disease progression or death, up to 4 years. |
| Progression-Free Survival (PFS) | PFS is defined as the time from the initiation of CDK4/6 inhibitor therapy to the date of documented disease progression or death from any cause, whichever occurs first. | From the date of therapy initiation up to 4 yrs |
| Progression-Free Survival (PFS) | PFS is defined as the time from the initiation of CDK4/6 inhibitor therapy to the date of documented disease progression or death from any cause, whichever occurs first. | From the date of therapy initiation up to 4 years (the period of retrospective medical records review). |
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Inclusion Criteria:
Exclusion Criteria:
patients diagnosed with double malignancy
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The study population consists of female patients diagnosed with hormone receptor-positive, HER2-negative (Luminal A or Luminal B) metastatic breast cancer who were managed and treated with CDK4/6 inhibitors at Sohag University Hospital and SCI . Data will be extracted from their existing medical records.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag university hospital | Sohag | Egypt |
regulations and hospital policies
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |