Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07704801

CDK4/6 Inhibitors in Metastatic HR-Positive Breast Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university hospital

Sohag, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. progression free survival

    Time frame: Up 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.

  2. Progression-Free Survival (PFS)

    Time frame: From the date of therapy initiation up to 4 yrs

    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.

  3. Progression-Free Survival (PFS)

    Time frame: From the date of therapy initiation up to 4 years (the period of retrospective medical records review).

    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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Acronym: OCDMBC

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.