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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%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Overall Response Rate (ORR)

Secondary outcome measures

Clinical Benefit Rate (CBR)

Grade 3-5 Treatment-related Toxicity Rate

Median Duration of Overall Response (DOR)

+2 more

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

Trastuzumab

2014

Completed Phase 4

~5190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Adrienne G. WaksLead Sponsor

3 Previous Clinical Trials

213 Total Patients Enrolled

3 Trials studying Breast Cancer

213 Patients Enrolled for Breast Cancer

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

848,439 Total Patients Enrolled

17 Trials studying Breast Cancer

6,454 Patients Enrolled for Breast Cancer

Adrienne Waks, MDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

171 Total Patients Enrolled

1 Trials studying Breast Cancer

171 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Are there any opportunities for individuals to take part in this clinical investigation?

"The clinicaltrials.gov platform suggests that this trial is not presently accepting participants. It was initially posted on April 1st 2024 and last edited on October 20th 2023, but there are 2441 other trials open for enrollment right now."

Answered by AI

Has the FDA approved Sacituzumab Govitecan in combination with Trastuzumab (or its Biosimilar)?

"The safety score of Sacituzumab Govitecan + Trastuzumab (or Biosimilar) was estimated at 2, as while there is some evidence supporting its safety, results in regards to efficacy are yet unknown."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After progrEssion on ENhertu (SATEEN)

Adrienne G. Waks 2023. "A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After progrEssion on ENhertu (SATEEN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06100874.