RecruitingPhase 2NCT06616987

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer

A Multicenter, Open-label, Single-arm, Clinical Trial to Evaluate the Preventive Effect of Pegylated G-CSF (PG) on Neutropenia in Patients With Metastatic Triple-negative Breast Cancer (mTNBC) Receiving Sacituzumab Govitecan (SG)


Sponsor

Yeon Hee Park

Enrollment

40 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying ways to prevent a serious side effect — dangerously low white blood cell counts (neutropenia) — in patients with metastatic triple-negative breast cancer (TNBC) who are receiving the drug sacituzumab govitecan. Neutropenia from this treatment increases infection risk, and the study is testing whether a specific preventive strategy can reduce this risk. **You may be eligible if...** - You are 19 or older - You have been confirmed to have metastatic triple-negative breast cancer (ER-, PR-, HER2-negative) - You are in good general health (ECOG score 0–1) - Your life expectancy is at least 12 weeks - Your disease is measurable or detectable on scans - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have active brain metastases that are not well-controlled - You have serious autoimmune disease or a history of severe immune-related reactions - Your organ function is insufficient for treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan with pegfilgrastim

▪ Sacituzumab Govitecan group \- Sacituzumab Govitecan 10mg/kg IV on CnD1 and D8 + Pegfilgrastim 6mg SC QD on CnD9


Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT06616987


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