I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Recruiting · Phase 2 · NCT01042379
Conditions: Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
At a glance
- Research payments reported, 2025
- $379,149
- U.S. investigators named
- 20
- Sites paid
- 20
- Planned or actual enrollment
- 5,000
About the trial
- Sponsor
- QuantumLeap Healthcare Collaborative
- Tested
- 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)
- Dates
- Started 2010-03-01; completion 2031-12
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-05-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Regeneron Pharmaceuticals, Inc. reported $379,149 in research payments for this study in 2025 (58 payments).
Products named: Libtayo
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Erica Stringer-reasor Hematology & Oncology · Birmingham, AL
- Christos Vaklavas, M.D. Hematology & Oncology · Birmingham, AL
- Timothy E. Albertson, MD, PHD, MPH Critical Care Medicine · Sacramento, CA
- Jody Y. Chiang Dentists (general) · San Diego, CA
- Amy J. Chien, M.D. Medical Oncology · San Francisco, CA
- Anne M. Wallace, M.D. Plastic Surgery · San Diego, CA
- Anthony Elias, MD Medical Oncology · Aurora, CO
- Jonathan Koff, M.D. Pulmonology · New Haven, CT
- Nathan K. Cobb, MD Pulmonology · Washington, DC
- Hyo S. Han, MD Medical Oncology · Tampa, FL
- Rita Nanda Hematology & Oncology · Chicago, IL
- Jane L. Meisel, MD Hospitalist · Boston, MA
- Gordon Srkalovic, MD Hematology & Oncology · Lansing, MI
- Judy C. Boughey, MD General Surgery · Rochester, MN
- Douglas Yee, M.D. Hematology & Oncology · Minneapolis, MN
- Alexandra Thomas, MD Hematology & Oncology · Winston Salem, NC
- Coral O. Omene, M.D., PH.D Medical Oncology · New York, NY
- Anthony Pietropaoli, MD Pulmonology · Rochester, NY
- Meghna S. Trivedi, MD Medical Oncology · New York, NY
- Amy S. Clark, MD Medical Oncology · Philadelphia, PA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Rutgers $118,052
- Strong Memorial Hospital, NY $69,889
- University of California San Francisco $51,450
- Mayo Clinic Rochester $42,573
- University of Minnesota $16,308
- Georgetown University $14,753
- University of Colorado $12,891
- Moffitt Cancer Center $10,005
- City of Hope National Medical Ctr $9,391
- University of Alabama Hospital, AL $8,809
- University of Chicago $7,074
- University of California San Diego $6,219
- Emory University $2,719
- University of Utah Hospital and Clinics, UT $2,367
- Columbia Nyc $2,071
- Edward W Sparrow Hospital, MI $1,699
- Hospital of Univ of Pennsylvania, PA $1,281
- Yale $815
- Wake Forest University Health Sciences $547
- University of California Davis Medical Center, CA $236
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.