ClinicalTrials.gov record
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
ClinicalTrials.gov ID: NCT01042379
Public ClinicalTrials.gov record NCT01042379. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 8, 2026, 5:06 AM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
Study identification
- NCT ID
- NCT01042379
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- QuantumLeap Healthcare Collaborative
- Other
- Enrollment
- 5,000 participants
Conditions and interventions
Conditions
Interventions
- ABT-888 Drug
- AMG 386 and Trastuzumab Drug
- AMG 386 with or without Trastuzumab Drug
- AMG 479 (Ganitumab) plus Metformin Drug
- ARV-471 Drug
- ARV-471 + Abemaciclib Drug
- ARV-471 + Letrozole Drug
- ARX788 Drug
- ARX788 + Cemiplimab Drug
- Amcenestrant Drug
- Amcenestrant + Abemaciclib Drug
- Amcenestrant + Letrozole Drug
- Cemiplimab Drug
- Cemiplimab plus REGN3767 Drug
- Dan222 + Niraparib Drug
- Datopotamab deruxtecan Drug
- Datopotamab deruxtecan + Durvalumab Drug
- Durvalumab plus Olaparib Drug
- Endoxifen + Abemaciclib Drug
- GSK 5733584 Drug
- GSK 5733584 + Dostarlimab Drug
- Ganetespib Drug
- Ivonescimab (20mg/kg Q3W) Drug
- Lasofoxifene Drug
- MK-2206 with or without Trastuzumab Drug
- Neratinib Drug
- Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab Drug
- Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab Drug
- PLX3397 Drug
- Patritumab and Trastuzumab Drug
- Pembrolizumab - 4 cycle Drug
- Pembrolizumab - 8 cycle Drug
- Pertuzumab and Trastuzumab Drug
- Rilvegostomig + TDXd Drug
- SD-101 + Pembrolizumab Drug
- SGN-LIV1A Drug
- SYD985 ([vic-]trastuzumab duocarmazine) Drug
- Sarilumab + Cemiplimab + Paclitaxel Drug
- Standard Therapy Drug
- T-DM1 and Pertuzumab Drug
- Talazoparib plus Irinotecan Drug
- Trilaciclib with or without trastuzumab + pertuzumab Drug
- Tucatinib plus trastuzumab and pertuzumab Drug
- VV1 + Cemiplimab Drug
- Z-endoxifen Drug
- Zanidatamab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2010
- Primary completion
- Nov 30, 2030
- Completion
- Nov 30, 2031
- Last update posted
- May 5, 2026
2010 – 2031
United States locations
- U.S. sites
- 42
- U.S. states
- 24
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Recruiting |
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | Not yet recruiting |
| University of Arizona | Tucson | Arizona | 85724 | Active, not recruiting |
| University of California - Davis, Comprehensive Cancer Center | Davis | California | 95817 | Recruiting |
| City of Hope | Duarte | California | 91010 | Recruiting |
| University of California San Diego | La Jolla | California | 92093-0698 | Recruiting |
| University of Southern California | Los Angeles | California | 90033 | Recruiting |
| HOAG Memorial Hospital Presbyterian | Newport Beach | California | 92663 | Recruiting |
| University of California San Francisco (UCSF) | San Francisco | California | 94115 | Recruiting |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06510 | Recruiting |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | Recruiting |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | Recruiting |
| University of Chicago | Chicago | Illinois | 60453 | Recruiting |
| Loyola University | Maywood | Illinois | 60153 | Recruiting |
| University of Kansas | Westwood | Kansas | 66205 | Active, not recruiting |
| Herbert-Herman Cancer Center, Sparrow Hospital | Lansing | Michigan | 48912 | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center | Saint Louis Park | Minnesota | 55416 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Recruiting |
| Laura and Isaac Perlmutter Cancer Center / NYU Langone Health | New York | New York | 10016 | Recruiting |
| Columbia University Medical Center | New York | New York | 10032 | Recruiting |
| University of Rochester Wilmot Cancer Institute | Rochester | New York | 14642 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44106 | Recruiting |
| The Ohio State University, Stefanie Spielman Comprehensive Breast Center | Columbus | Ohio | 43212 | Recruiting |
| Oregon Health & Science Institute (OHSU) | Portland | Oregon | 97239 | Recruiting |
| University of Pennsylvania (U Penn) | Philadelphia | Pennsylvania | 19104 | Recruiting |
| University Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Active, not recruiting |
| Sanford Clinical Research | Sioux Falls | South Dakota | 57104 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 27204 | Active, not recruiting |
| University of Texas, Southwestern Medical Center | Dallas | Texas | 75390-9155 | Active, not recruiting |
| University of Texas, M.D. Anderson Cancer Center | Houston | Texas | 77230-1439 | Active, not recruiting |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | Recruiting |
| Inova Health System | Falls Church | Virginia | 22042 | Active, not recruiting |
| Swedish Cancer Institute | Seattle | Washington | 98104 | Active, not recruiting |
| University of Washington | Seattle | Washington | 98115 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01042379, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01042379 live on ClinicalTrials.gov.