RecruitingPhase 2NCT06263543

Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC

SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW/ULTRA LOW MetaStatic Breast Cancer


Sponsor

Reshma L. Mahtani, D.O.

Enrollment

75 participants

Start Date

Jun 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the best order (sequencing) to give two types of targeted drug therapies — called antibody-drug conjugates — in patients with advanced breast cancer that is hormone receptor-positive and has low or very low levels of the HER2 protein. **You may be eligible if...** - You are 18 or older - You have metastatic or advanced breast cancer that cannot be surgically removed - Your cancer tests positive for hormone receptors (estrogen or progesterone) and has low or very low HER2 expression - Your cancer has continued to grow despite hormone therapy - You have received prior chemotherapy for metastatic disease **You may NOT be eligible if...** - Your cancer is HER2-positive at a standard level - You have certain serious heart, liver, or lung conditions - You have active brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab govitecan

IV infusion of 10 mg/kg on Days 1 and 8 of each continuous and consecutive 21-day cycles. The first infusion will last approximately 3 hours and subsequent infusions will last 1-2 hours if prior infusions were well tolerated.


Locations(3)

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

Winship Cancer Institute at Emory University

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT06263543


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