Skip to content

CDK4/6 Inhibitors in Metastatic HR-Positive Breast Cancer

RETROSPECTIVE STUDY OF OUTCOME OF CDK4/6 INHIBITORS IN METASTATIC LUMINAL A AND LUMINAL B BREAST CANCER

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07704801
Acronym
OCDMBC
Enrollment
300
Registered
2026-07-15
Start date
2021-01-01
Completion date
2027-04-01
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Brief summary

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.

Detailed description

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.

Interventions

DRUGCDK4/6 inhibitors

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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patients who are more than 18 years old at time of diagnosis and less than 80 years * metastatic breast cancer luminal A and luminal B of either sex

Exclusion criteria

* patients diagnosed with double malignancy * patients with incomplete medical records * patients with organ failure

Design outcomes

Primary

MeasureTime frameDescription
progression free survivalUp to 4 years أو From initiation of CDK4/6 inhibitor therapy to disease progression or death, up to 4 years.Progression-free survival is defined as the time from initiation of CDK4/6 inhibitor therapy until documented disease progression or death from any cause.
Progression-Free Survival (PFS)From the date of therapy initiation up to 4 yrsPFS 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026