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NCT01042379 · ClinicalTrials.gov registry record · Phase 2
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
A Phase 2 study of Breast Cancer and Breast Neoplasms, sponsored by QuantumLeap Healthcare Collaborative.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 5,000
- Enrollment target
- 20
- Study locations
NCT01042379 is a Phase 2 study of Breast Cancer and Breast Neoplasms that is actively recruiting participants, run by QuantumLeap Healthcare Collaborative. The registered enrollment target is 5,000 participants, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (79% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT01042379, a Phase 2 study of Breast Cancer and Breast Neoplasms, is actively recruiting participants, sponsored by QuantumLeap Healthcare Collaborative.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 5,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
Conditions Studied
Interventions
- DRUG Standard Therapy
- DRUG AMG 386 with or without Trastuzumab
- DRUG AMG 479 (Ganitumab) plus Metformin
- DRUG MK-2206 with or without Trastuzumab
- DRUG AMG 386 and Trastuzumab
Study Locations (20)
California
- University of California - Davis, Comprehensive Cancer Center - Davis
- City of Hope - Duarte
- University of California San Diego - La Jolla
- University of Southern California - Los Angeles
- HOAG Memorial Hospital Presbyterian - Newport Beach
- University of California San Francisco (UCSF) - San Francisco
Arizona
- Mayo Clinic - Scottsdale - Scottsdale
- University of Arizona - Tucson
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
- Moffitt Cancer Center - Tampa
Illinois
- University of Chicago - Chicago
- Loyola University - Maywood
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- University of Colorado Cancer Center - Aurora
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2010-03-01 |
| Est. Completion | 2031-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01042379
The ClinicalTrials.gov registry entry for NCT01042379 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (79% higher). The listed sponsor is QuantumLeap Healthcare Collaborative, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Standard Therapy is the first listed.
NCT01042379 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT01042379 about?
NCT01042379 is a clinical study titled "I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer". The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic reso...
What is the current status of trial NCT01042379?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 5,000 participants. The study started on 2010-03-01. Estimated completion is 2031-12.
What conditions does trial NCT01042379 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer, HER2-Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer.
What interventions are being tested in trial NCT01042379?
The interventions under investigation include: Standard Therapy (DRUG), AMG 386 with or without Trastuzumab (DRUG), AMG 479 (Ganitumab) plus Metformin (DRUG), MK-2206 with or without Trastuzumab (DRUG), AMG 386 and Trastuzumab (DRUG).
Who is sponsoring clinical trial NCT01042379?
This trial is sponsored by QuantumLeap Healthcare Collaborative, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01042379 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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