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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met