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NCT05868226 · ClinicalTrials.gov registry record · Phase 1
PRE-I-SPY Phase I/Ib Oncology Platform Program
A Phase 1 study of Metastatic Breast Cancer and Triple Negative Breast Cancer, sponsored by QuantumLeap Healthcare Collaborative.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 124
- Enrollment target
- 7
- Study locations
NCT05868226: Recruiting Phase 1 study of Metastatic Breast Cancer and Triple Negative Breast Cancer, sponsored by QuantumLeap Healthcare Collaborative.
NCT05868226 is a Phase 1 study of Metastatic Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by QuantumLeap Healthcare Collaborative. The registered enrollment target is 124 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (39% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05868226, a Phase 1 study of Metastatic Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by QuantumLeap Healthcare Collaborative.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 124 participants
- Enrollment target
- 7
- Study locations
Study Summary
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
Primary Outcome
Evaluate the number of adverse events related to the treatment according to the current version of CTCAE during the trial.
Conditions Studied
Interventions
- DRUG Tucatinib
- DRUG Zanidatamab
- DRUG ALX148
- DRUG Fam-Trastuzumab Deruxtecan-Nxki
Study Locations (7)
Illinois
- The University of Chicago Medicine Comprehensive Cancer Center - Chicago
- UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital - New Lenox
- UChicago Medicine Orland Park - Orland Park
Alabama
- The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center - Birmingham
Florida
- Moffitt Cancer Center - Tampa
Minnesota
- University of Minnesota Masonic Cancer Center - Minneapolis
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2029-12-30 |
| Phase | Phase 1 |
What NCT05868226 shows while recruiting
NCT05868226 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (39% lower).
The record links to 10 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Tucatinib is the first listed.
NCT05868226 lists 7 locations in 5 states (Illinois, Alabama, Florida).
Frequently Asked Questions
What is clinical trial NCT05868226 about?
NCT05868226 is a clinical study titled "PRE-I-SPY Phase I/Ib Oncology Platform Program". I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT...
What is the current status of trial NCT05868226?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2023-02-15. Estimated completion is 2029-12-30.
What conditions does trial NCT05868226 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Triple Negative Breast Cancer, Metastatic Cancer, HER2-positive Breast Cancer, HER2-Negative Breast Cancer.
What interventions are being tested in trial NCT05868226?
The interventions under investigation include: Tucatinib (DRUG), Zanidatamab (DRUG), ALX148 (DRUG), Fam-Trastuzumab Deruxtecan-Nxki (DRUG).
Who is sponsoring clinical trial NCT05868226?
This trial is sponsored by QuantumLeap Healthcare Collaborative, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05868226 being conducted?
This trial has 7 study locations across Alabama, Florida, Illinois, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05868226's enrollment target sits among peer trials
124 50th of 139 higher than 90 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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