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NCT05101564 · ClinicalTrials.gov registry record · Phase 2
Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer
A Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, sponsored by Jennifer Lee Caswell-Jin.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT05101564: Completed Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, sponsored by Jennifer Lee Caswell-Jin.
NCT05101564 is a Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer that has completed, run by Jennifer Lee Caswell-Jin. The registered enrollment target is 19 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05101564, a Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, has completed, sponsored by Jennifer Lee Caswell-Jin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being tested based on the specific gene changes in the tumor. Not every tumor will have a gene change that is being studied.
Primary Outcome
The primary outcome is the percentage change in Ki67 expression comparing pre-treatment to on-treatment specimens. Ki67 values were log-transformed for analysis, and results are summarized as the mean percentage change with 95% confidence intervals.
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Fulvestrant
- DRUG Alpelisib
- DRUG Zotatifin
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2023-03-20 |
| Est. Completion | 2024-06-03 |
| Phase | Phase 2 |
What the finished NCT05101564 record still lists
NCT05101564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 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 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Tamoxifen is the first listed.
NCT05101564 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05101564 about?
NCT05101564 is a clinical study titled "Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer". The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being teste...
What is the current status of trial NCT05101564?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2023-03-20. Estimated completion is 2024-06-03.
What conditions does trial NCT05101564 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-Negative Breast Cancer, ER Positive Breast Cancer.
What interventions are being tested in trial NCT05101564?
The interventions under investigation include: Tamoxifen (DRUG), Fulvestrant (DRUG), Alpelisib (DRUG), Zotatifin (DRUG).
Who is sponsoring clinical trial NCT05101564?
This trial is sponsored by Jennifer Lee Caswell-Jin, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05101564 being conducted?
This trial has 1 study location across California. 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 NCT05101564's enrollment target sits among peer trials
19 1114th of 1224 higher than 108 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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