What does this research mean for the field?

CDK4/6 inhibitors are associated with an increased risk of venous thromboembolism (VTE) in patients with HR+/HER2- breast cancer. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

What question did this study set out to answer?

The research aims to evaluate if CDK4/6 inhibitors increase thrombotic risk among HR+/HER2- breast cancer patients.

January 10, 2026Breast Cancer Targets and Therapy0 citationsOpen Access

Assessing Thrombotic Risk in Patients with HR+/HER2- Breast Cancer Receiving CDK4/6 Inhibitors: Insights from Real-World Data from the Middle East

NANada Alsuhebany AAA. AlanaziKing Fahd Medical City MAMohammed AlzahraniKing Saud bin Abdulaziz University for Health Sciences

Key Result

CDK4/6 inhibitors were associated with an increased risk of venous thromboembolism (VTE) in patients with HR+/HER2- breast cancer.

Key Points

The research aims to evaluate if CDK4/6 inhibitors increase thrombotic risk among HR+/HER2- breast cancer patients.
Analysis of real-world data from Middle East patients
Assessment of thrombotic events during CDK4/6 inhibitor treatment
Evaluation of venous thromboembolism occurrences
Increased risk of thrombotic events associated with CDK4/6 inhibitors
Evidence of elevated venous thromboembolism rates during treatment
Potential safety concerns necessitating closer monitoring

Structured PICO

What is the real-world incidence of thrombotic events in patients with HR+/HER2- breast cancer receiving CDK4/6 inhibitors?

Population

447 adult patients (≥18 years) with HR+/HER2- breast cancer (advanced stage or early-stage high-risk) receiving CDK4/6 inhibitors for at least one month, median age 56, 97.3% female, from two centers in Saudi Arabia.

Intervention

CDK4/6 inhibitors (palbociclib, abemaciclib, or ribociclib) combined with hormone therapy

Outcome

Incidence of thrombotic events including VTE (symptomatic and asymptomatic DVT and PE) and arterial thrombosissafety

Real-world data indicates an 11.8% incidence of thrombotic events in breast cancer patients on CDK4/6 inhibitors, higher than reported in clinical trials, emphasizing the need for VTE risk assessment.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

To assess whether CDK4/6 inhibitors might be associated with an increased risk of thrombotic events including venous thromboembolism (VTE).

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