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Antibody-drug Conjugate

Sacituzumab Govitecan + Trastuzumab for Breast Cancer

Phase 2

Recruiting

Led By Adrienne Waks, MD

Research Sponsored by Adrienne G. Waks

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one measurable lesion that can be accurately assessed at baseline by CT (MRI where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.149

ECOG performance status of 0 - 2 (Karnofsky > 50%)

Must not have

Known leptomeningeal disease

Known brain metastases that are untreated, symptomatic, or require corticosteroid therapy to control symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how safe and effective sacituzumab govitecan and trastuzumab are in treating metastatic HER2+ breast cancer.

Who is the study for?

This trial is for adults with HER2+ metastatic breast cancer who've had specific prior treatments including a taxane, trastuzumab, and T-DXd. They must have at least one measurable tumor, normal organ function, an ECOG performance status of 0-2, and no major health issues that could interfere with the study. Pregnant or breastfeeding individuals are excluded.

What is being tested?

The trial tests sacituzumab govitecan combined with trastuzumab (Herceptin or similar) to see if they're safe and effective against advanced breast cancer that has worsened after previous treatment. Participants will receive these drugs as part of their therapy regimen.

What are the potential side effects?

Potential side effects include allergic reactions to the drugs used in this study (sacituzumab govitean and trastuzumab), as well as possible side effects from antibody-drug conjugates like nausea, fatigue, low blood cell counts leading to increased infection risk, diarrhea, and liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor that can be measured by CT scan or MRI.

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I can take care of myself but might not be able to do heavy physical work.

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My organ and bone marrow functions are normal.

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My cancer is HER2 positive, either at the original site or where it has spread.

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My breast cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to the lining of my brain and spinal cord.

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I have brain metastases that are either untreated, causing symptoms, or need steroids for symptom control.

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I do not have any severe illnesses or conditions that would stop me from following the study's requirements.

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I have not had major surgery in the last 2 weeks.

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I have a genetic condition that increases my risk for certain side effects from irinotecan.

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I have not been treated with Trop-2 targeted therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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

Overall Response Rate (ORR)

Secondary study objectives

Clinical Benefit Rate (CBR)

Grade 3-5 Treatment-related Toxicity Rate

Median Duration of Overall Response (DOR)

+2 more

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: Sacituzumab Govitecan + Trastuzumab (or Biosimilar)Experimental Treatment3 Interventions

Participants will complete the following: * Baseline visit with assessments. * CT or MRI scans every 9 weeks for 27 weeks and then every 12 weeks. * Echocardiogram or MUGA scan every 12 weeks for 24 weeks and then every 16 weeks. * Cycle 1 through Cycle 2: * Days 1 and 8 of 21 day cycle: Predetermined dose of Sacituzumab govitecan 1x daily. * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab either intravenously or subcutaneously 1x daily. * Cycle 2: * Day 1: Optional tumor biopsy * Days 1 and 8 of 21 day cycle: Predetermined dose of Sacituzumab govitecan 1x daily. * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab either intravenously or subcutaneously 1x daily. * Cycle 3 through End of Treatment: * Days 1 and 8 of 21 day cycle: Predetermined dose of Sacituzumab govitecan 1x daily. * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab either intravenously or subcutaneously 1x daily. * End of treatment: * Follow up visits every 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan

2019

Completed Early Phase 1

~30

Trastuzumab

2014

Completed Phase 4

~5190