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Monoclonal Antibodies

Sacituzumab Govitecan for Brain Metastases from Breast Cancer

Phase 2
Recruiting
Led By Andrew J Brenner
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have Zubrod performance status 0 or 1
Participants must have histologically confirmed HER2-negative invasive breast cancer that has metastasized to the brain
Must not have
Participants must not have had more than 2 seizures within 28 days prior to registration
Participants must not be receiving or be planning to receive concomitantly any other anti-cancer therapy, including endocrine therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is studying sacituzumab govitecan to see how well it works in treating patients with HER2-negative breast cancer that has spread to the brain.

Who is the study for?
This trial is for adults with HER2-negative breast cancer that has spread to the brain. They must have measurable brain metastasis, experienced CNS progression after treatment, and be in good physical condition (Zubrod status 0 or 1). Patients should not have had more than two seizures recently, no recent certain treatments or infections like HIV/hepatitis, and cannot be pregnant.
What is being tested?
The trial tests Sacituzumab Govitecan's effectiveness on patients with brain metastases from breast cancer. It's a targeted therapy combining an antibody with chemotherapy to attack cancer cells directly without harming normal cells.
What are the potential side effects?
Sacituzumab Govitecan may cause side effects such as nausea, fatigue, hair loss (alopecia), low blood cell counts leading to increased infection risk or bleeding problems, and potential allergic reactions due to its monoclonal antibody component.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is HER2-negative and has spread to my brain.
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I have a brain scan showing a tumor larger than 1 cm.
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My brain cancer progressed after treatment like surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had 2 or fewer seizures in the last 28 days.
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I am not on, nor planning to start, any other cancer treatments.
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I am not currently on steroids or other immune-weakening medicines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Incidence of adverse events
Overall survival
Progression-free survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sacituzumab govitecan)Experimental Treatment1 Intervention
Patients receive sacituzumab govitecan IV over 1-3 hours on days 1 and 8. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan
2019
Completed Early Phase 1
~30

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
265,030 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
Gilead SciencesIndustry Sponsor
1,098 Previous Clinical Trials
860,425 Total Patients Enrolled
16 Trials studying Breast Cancer
6,212 Patients Enrolled for Breast Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,143 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer

Media Library

Sacituzumab Govitecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04647916 — Phase 2
Breast Cancer Research Study Groups: Treatment (sacituzumab govitecan)
Breast Cancer Clinical Trial 2023: Sacituzumab Govitecan Highlights & Side Effects. Trial Name: NCT04647916 — Phase 2
Sacituzumab Govitecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04647916 — Phase 2
~22 spots leftby Dec 2027
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