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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

265,126 Total Patients Enrolled

54 Trials studying Breast Cancer

65,326 Patients Enrolled for Breast Cancer

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

848,435 Total Patients Enrolled

17 Trials studying Breast Cancer

6,454 Patients Enrolled for Breast Cancer

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,767 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risk factors should be taken into account when administering Sacituzumab Govitecan?

"The safety of Sacituzumab Govitecan was assessed as a 2, given the Phase 2 trial status, which implies that there is evidence supporting its security but not yet any proof backing its effectiveness."

Answered by AI

Is this an unprecedented research endeavor?

"Investigations into Sacituzumab Govitecan began in 2018; the very first trial was sponsored by Hoffmann-La Roche and took place that year. After successful Phase 1 & 2 trials, 33 active studies related to this drug are currently being held across 418 cities and 32 countries."

Answered by AI

Are there any existing investigations that utilize Sacituzumab Govitecan?

"Sacituzumab Govitecan was initially tested in 2018 at Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley. This antibody has seen two completed trials, with 33 active ones transpiring across the United States, a good number of which are taking place in Clinton, North carolina."

Answered by AI

Is this research venture currently taking in participants?

"Based on the information available through clinicaltrials.gov, this trial is actively seeking participants and has been open since December 15th 2020. The posting was last revised on November 21st 2022."

Answered by AI

How many individuals have consented to take part in this research project?

"In order to commence the trial, 44 participants that meet the criteria must be enrolled. Gilead Sciences is responsible for running this study at two locations: Southeastern Medical Oncology Center-Clinton in Clinton, North carolina and Baptist Memorial Hospital and Cancer Center-Memphis in Memphis, Tennessee."

Answered by AI

How many sites are administering this clinical trial?

"This clinical trial has 100 recruiting locations, including at least three in Clinton, Memphis and Southhaven. It is wise to select the site closest so that you can limit your travel during participation."

Answered by AI