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Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT06616987•Yeon Hee Park

View on ClinicalTrials.gov

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

Detailed Description

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

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed Informed Consent Form (ICF) prior to participation in any study-related activities.
•2. Patients aged ≥19 years at the time of signing ICF.
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•4. Life expectancy of ≥ 12 weeks.
•5. Histologically confirmed TNBC per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria based on local testing on the most recent analyzed biopsy. Triple-negative is defined as \<1% expression for estrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2) (0-1+ by IHC or 2+ and negative by in situ hybridization \[ISH) test\].
•6. Metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
•7. Refractory to at least one, and no more than two, prior standard of care chemotherapy regimens for unresectable locally advanced or MBC. PARP inhibitor could have been counted as prior chemotherapy for purposes of study eligibility.
•8. All patients must have been previously treated with taxanes regardless of disease stage (adjuvant, neoadjuvant, or advanced), unless contraindicated for a given patient.
•9. Measurable or non-measurable, but evaluable disease, as per RECIST v.1.1. Patients with bone-only metastases are also eligible.
•10. Brain MRI must be done for patients with suspicion of brain metastases and patient must have stable central nervous system (CNS) disease for at least 4 weeks after local therapy, without neurological symptoms, and off anticonvulsants and steroids (no more than 10mg/day prednisone or its equivalent) for at least 2 weeks before first dose of study treatment.
+26 more criteria

Exclusion Criteria

•1. Prior treatment with topoisomerase 1 inhibitors as a free form or as other formulations.
•2. Received any prior treatment with a Trop-2-directed ADC.
•3. Patients with carcinomatous meningitis.
•4. Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.
•5. Patients positive for HIV-1 or -2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
•6. Have active hepatitis B virus (HBV) (defined as having a positive hepatitis B surface antigen test) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
•1. Patients who test positive for hepatitis B surface antigen will be excluded.

Locations (1)

Samsung Medical Center

Seoul, South Korea

Key Dates

Start Date

July 3, 2025

Primary Completion Date

June 30, 2027

Completion Date

December 31, 2027

Last Updated

August 28, 2025

Enrollment

ESTIMATED participants

Conditions

Breast Cancer Metastatic

Interventions

Sacituzumab Govitecan with pegfilgrastim

DRUG

Contacts

Yeon Hee Park, Ph.D

CONTACT

82-2-3410-3459 yhparkhmo@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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