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NCT06100874 · ClinicalTrials.gov registry record · Phase 2
A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)
A Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female, sponsored by Adrienne G. Waks.
- Active
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 4
- Study locations
NCT06100874: Active Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female, sponsored by Adrienne G. Waks.
NCT06100874 is a Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female that is active but no longer recruiting, run by Adrienne G. Waks. The registered enrollment target is 28 participants, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06100874, a Phase 2 study of HER2-positive Breast Cancer and Breast Cancer Female, is active but no longer recruiting, sponsored by Adrienne G. Waks.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 4
- Study locations
Study Summary
This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: * Sacituzumab govitecan (a type of antibody-drug conjugate) * Trastuzumab (Herceptin) (a type of monoclonal antibody) * Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) * Trastuzumab biosimilar drug
Primary Outcome
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Sacituzumab Govitecan
- DRUG Trastuzumab and Hyaluronidase-oysk
Study Locations (4)
Massachusetts
- Dana Farber Cancer Institite - Boston
- DFCI @ South Shore Hospital - South Weymouth
Florida
- Miami Cancer Institute at Baptist Health - Miami
Tennessee
- SCRI Oncology Partners - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2023-11-20 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
What the registry record for NCT06100874 still lists
NCT06100874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.
NCT06100874 reports a single indexed study location in Massachusetts, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06100874 about?
NCT06100874 is a clinical study titled "A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)". This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: * Sacituzumab govitecan (a...
What is the current status of trial NCT06100874?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2023-11-20. Estimated completion is 2027-11-30.
What conditions does trial NCT06100874 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, Breast Cancer Female, Breast Cancer Metastatic.
What interventions are being tested in trial NCT06100874?
The interventions under investigation include: Trastuzumab (DRUG), Sacituzumab Govitecan (DRUG), Trastuzumab and Hyaluronidase-oysk (DRUG).
Who is sponsoring clinical trial NCT06100874?
This trial is sponsored by Adrienne G. Waks, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06100874 being conducted?
This trial has 4 study locations across Florida, Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06100874's enrollment target sits among peer trials
28 44th of 58 higher than 13 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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