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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Reshma L. Mahtani, D.O.
Study ID
NCT06263543
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab govitecan — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 17, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab Govitecan (SG) Infusion
    SG will be administered on Days 1 and 8 of continuous 21-day cycles at 10 mg/kg via intravenous (IV) infusion until disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 24 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCLA Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90404
Aditya Bardia, M.D.
[email protected]
(310) 586-2093
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Reshma L Mahtani, D.O.
[email protected]
(786) 596-2000
Krystal Fernandez
[email protected]
(786) 596-2000
Winship Cancer Institute at Emory UniversityAtlantaGeorgia30322
Kevin Kalinsky, M.D., M.S.
[email protected]
(404) 778-0519

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UCLA Jonsson Comprehensive Cancer Center· Los Angeles, CAMiami Cancer Institute at Baptist Health, Inc.· Miami, FLWinship Cancer Institute at Emory University· Atlanta, GA

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