I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01042379
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 5,000 participants
Conditions and interventions
Conditions
Interventions
- 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
- T-DM1 and Pertuzumab Drug
- Pertuzumab and Trastuzumab Drug
- Ganetespib Drug
- ABT-888 Drug
- Neratinib Drug
- PLX3397 Drug
- Pembrolizumab - 4 cycle Drug
- Talazoparib plus Irinotecan Drug
- Patritumab and Trastuzumab Drug
- Pembrolizumab - 8 cycle Drug
- SGN-LIV1A Drug
- Durvalumab plus Olaparib Drug
- SD-101 + Pembrolizumab Drug
- Tucatinib plus trastuzumab and pertuzumab Drug
- Cemiplimab Drug
- Cemiplimab plus REGN3767 Drug
- Trilaciclib with or without trastuzumab + pertuzumab Drug
- SYD985 ([vic-]trastuzumab duocarmazine) Drug
- Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab Drug
- Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab Drug
- Amcenestrant Drug
- Amcenestrant + Abemaciclib Drug
- Amcenestrant + Letrozole Drug
- ARX788 Drug
- ARX788 + Cemiplimab Drug
- VV1 + Cemiplimab Drug
- Datopotamab deruxtecan Drug
- Datopotamab deruxtecan + Durvalumab Drug
- Zanidatamab Drug
- Lasofoxifene Drug
- Z-endoxifen Drug
- ARV-471 Drug
- ARV-471 + Letrozole Drug
- ARV-471 + Abemaciclib Drug
- Endoxifen + Abemaciclib Drug
- Rilvegostomig + TDXd Drug
- Dan222 + Niraparib Drug
- Sarilumab + Cemiplimab + Paclitaxel Drug
- GSK 5733584 Drug
- GSK 5733584 + Dostarlimab Drug
- Ivonescimab (20mg/kg Q3W) 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 Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01042379 live on ClinicalTrials.gov.