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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05868226
The ClinicalTrials.gov registry entry for NCT05868226 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (39% lower). The listed sponsor is QuantumLeap Healthcare Collaborative, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 5 distinct geographic areas - top geographies include 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.
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