Actively Recruiting

Phase 2
Age: 19Years +
All Genders
NCT06616987

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

Led by Yeon Hee Park · Updated on 2025-08-28

40

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any study activities
  • Age 19 years or older at consent
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Histologically confirmed triple-negative breast cancer with specific receptor criteria
  • Metastatic disease not suitable for curative surgery
  • Refractory to one or two prior standard chemotherapy regimens
  • Prior taxane treatment unless contraindicated
  • Measurable or evaluable disease including bone-only metastases
  • Stable brain metastases for at least 4 weeks without symptoms and off steroids and anticonvulsants
  • Adequate organ function including blood counts, liver, kidney, and coagulation parameters
  • Resolution of prior treatment side effects to mild levels except alopecia
  • Use of contraception during and for 6 months after treatment for patients of childbearing potential
  • Completed prior cancer treatments at least 2 weeks before first study drug infusion; biologics at least 4 weeks prior
Not Eligible

You will not qualify if you...

  • Prior treatment with topoisomerase 1 inhibitors or Trop-2-directed ADCs
  • Carcinomatous meningitis
  • Known hypersensitivity to study drugs or their components
  • HIV with Kaposi sarcoma or Multicentric Castleman Disease
  • Active hepatitis B or C infection or detectable viral loads
  • Planned surgery during study except minor procedures
  • Active second malignancy except certain low-risk or treated cancers
  • Recent significant bleeding, intestinal obstruction, or gastrointestinal perforation
  • Active or prior inflammatory bowel disease causing baseline diarrhea
  • Infection requiring antibiotics within 1 week before study drug
  • Other medical or psychiatric conditions interfering with study
  • Pregnant or breastfeeding women
  • Participation in other interventional clinical trials
  • Use of investigational drugs within 28 days or 5 half-lives before study drug start
  • Any condition posing undue risk per investigator or sponsor opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

Y

Yeon Hee Park, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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