CDK4/6 Inhibitors in Metastatic HR-Positive Breast Cancer

NCT07704801 | Active Not Recruiting

• 1 other identifier: Soh-Med-26-6-5MS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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).

Study Arms (2)

luminal A subgroup

patients diagnosed with metastatic breast cancer

Drug: CDK4/6 inhibitors

luminal B subgroup

patients diagnosed with metastatic breast cancer

Drug: CDK4/6 inhibitors

Interventions

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.

luminal A subgroup; luminal B subgroup

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc. Candidate, Department of Clinical Oncology, Sohag University

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: January 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)