Trials / Recruiting
RecruitingNCT06263543
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Reshma L. Mahtani, D.O. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast Cancer
- Metastatic Breast Cancer
- Advanced Breast Cancer
- Hormone-receptor-positive Breast Cancer
- Human Epidermal Growth Factor 2 Low Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sacituzumab 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. |
Timeline
- Start date
- 2024-06-17
- Primary completion
- 2026-06-01
- Completion
- 2026-12-01
- First posted
- 2024-02-16
- Last updated
- 2025-12-26
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06263543. Inclusion in this directory is not an endorsement.