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NCT05143229 · ClinicalTrials.gov registry record · Phase 1
Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by University of Kansas Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 7
- Study locations
NCT05143229: Active Phase 1 study of Breast Cancer, sponsored by University of Kansas Medical Center.
NCT05143229 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by University of Kansas Medical Center. The registered enrollment target is 18 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05143229, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by University of Kansas Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for treatment of metastatic or locally recurrent HER2-negative breast cancer.
Primary Outcome
Standard 3+3 dose escalation design (three dose levels of alpelisib plus sacituzumab govitecan) with dose-limiting toxicities (DLT) assessed during the first treatment cycle. If two or more of the six patients experienced a dose-limiting toxicity, dosing escalation would cease and maximum tolerated dose (MTD) would be reached. RP2D was the next lower dose at which \<1/6 subjects experienced a DLT.
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan
- DRUG Alpelisib
Study Locations (7)
Kansas
- The University of Kansas Clinical Research Center - Fairway
- The University of Kansas Cancer Center - Overland Park - Overland Park
- The University of Kansas Cancer Center - Indian Creek - Overland Park
- The University of Kansas Cancer Center - Westwood
Missouri
- The University of Kansas Cancer Center - North Kansas City Hospital - Kansas City
- The University of Kansas Cancer Center - North - Kansas City
- The University of Kansas Cancer Center - Lee's Summit - Lee's Summit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What the registry record for NCT05143229 still lists
NCT05143229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Sacituzumab govitecan is the first listed.
NCT05143229 lists 7 locations in 2 states (Kansas, Missouri).
Frequently Asked Questions
What is clinical trial NCT05143229 about?
NCT05143229 is a clinical study titled "Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer". This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for treatment of metastatic or locally recurrent HER2-negative breast cancer.
What is the current status of trial NCT05143229?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-03-28. Estimated completion is 2025-12.
What conditions does trial NCT05143229 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05143229?
The interventions under investigation include: Sacituzumab govitecan (DRUG), Alpelisib (DRUG).
Who is sponsoring clinical trial NCT05143229?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05143229 being conducted?
This trial has 7 study locations across Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT05143229's enrollment target sits among peer trials
18 1118th of 1224 higher than 97 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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