Clinical trialNCT01042379RecruitingPhase 2Interventional

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

SponsorQuantumLeap Healthcare CollaborativeEnrollment5,000AngiosarcomaBreast CancerBreast NeoplasmsBreast TumorsEarly-stage Breast CancerHER2-negative Breast Cancer+5 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Laura Esserman, MD, MBA
University of California, San Francisco
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

42 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
Erica Stringer-Reasor, MD
Recruiting
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
Donald Northfelt, MD
Not, yet, recruiting
University of Arizona
Tucson, Arizona, United States
Active, not recruiting
University of California - Davis, Comprehensive Cancer Center
Davis, California, United States
Mili Arora, MD
Recruiting
City of Hope
Duarte, California, United States
Hope Rugo, MD
Recruiting
University of California San Diego
La Jolla, California, United States
Anne Wallace, MD
Recruiting
University of Southern California
Los Angeles, California, United States
Evanthia Roussos Torres, MD
Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Chaitali Nangia, MD
Recruiting
University of California San Francisco (ucsf)
San Francisco, California, United States
Amy Jo Chien, MD
Recruiting
University of Colorado Cancer Center
Aurora, Colorado, United States
Anthony Elias, MDVirgnia Borges, MD
Recruiting
Yale Cancer Center
New Haven, Connecticut, United States
Lajos Pusztai, MDMariya Rozenblit, MDTara Snaft, MD
Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Claudine Isaacs, MD
Recruiting
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Hyo Heather Han, MD
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Heather Han, MD
Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Kevin Kalinsky, MD
Recruiting
University of Chicago
Chicago, Illinois, United States
Rita Nanda, MD
Recruiting
Loyola University
Maywood, Illinois, United States
Kathy S Albain, MD
Recruiting
University of Kansas
Westwood, Kansas, United States
Active, not recruiting
Herbert-Herman Cancer Center, Sparrow Hospital
Lansing, Michigan, United States
Brittani Thomas, DO
Recruiting
University of Minnesota
Minneapolis, Minnesota, United States
Douglas Yee, MD
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Judy C Boughey, MD
Recruiting
Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center
Saint Louis Park, Minnesota, United States
Satya Bommakanti, MD
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Coral Omene, MD, PhD
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Ellis Levine, MD
Recruiting
Columbia University Medical Center
New York, New York, United States
Meghana Trivedi, MD
Recruiting
Laura and Isaac Perlmutter Cancer Center / Nyu Langone Health
New York, New York, United States
Nancy Chan, MD
Recruiting
University of Rochester Wilmot Cancer Institute
Rochester, New York, United States
Carla Folksm, MD
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Jesus D Anampa
Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Marissa Howard-McNatt, MD
Recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Julie Lang, MD
Recruiting
the Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States
Nicole Williams, MD
Recruiting
Oregon Health & Science Institute (ohsu)
Portland, Oregon, United States
Alexandra Zimmer, MD
Recruiting
University of Pennsylvania (u Penn)
Philadelphia, Pennsylvania, United States
Amy Clark, MD
Recruiting
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Active, not recruiting
Sanford Clinical Research
Sioux Falls, South Dakota, United States
Amy Sanford, MD
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Active, not recruiting
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
Active, not recruiting
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States
Active, not recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Christos Vaklavas, MD
Recruiting
Inova Health System
Falls Church, Virginia, United States
Active, not recruiting

2 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

(R)-2-(2-methylpyrrolidin-2-yl)-1H-benzo(d)imidazole-4-carboxamide dihydrochloride →AMG 386 and Trastuzumab →AMG 386 with or without Trastuzumab →AMG 479 plus Metformin →Arv-471 →ARV-471 + Abemaciclib →ARV-471 + Letrozole →ARX788ARX788 + CemiplimabAmcenestrant →Amcenestrant + Abemaciclib →Amcenestrant + Letrozole →Cemiplimab →Cemiplimab plus REGN3767Dan222 + NiraparibDatopotamab deruxtecan →Datopotamab deruxtecan + DurvalumabDurvalumab plus OlaparibEndoxifen + AbemaciclibGSK 5733584GSK 5733584 + DostarlimabGanetespib →IvonescimabLasofoxifeneMK-2206 with or without TrastuzumabNeratinib →Paclitaxel + Encequidar + Dostarlimab + Carboplatin with or without trastuzumabPaclitaxel + Encequidar + Dostarlimab with or without trastuzumabPexidartinib →Patritumab and TrastuzumabPembrolizumab - 4 cyclePembrolizumab - 8 cyclePertuzumab and TrastuzumabRilvegostomig + TDXdSD-101 + PembrolizumabSGN-LIV1ASYD985Sarilumab + Cemiplimab + PaclitaxelStandard TherapyT-DM1 and PertuzumabTalazoparib plus IrinotecanTrilaciclib with or without trastuzumab + pertuzumabTucatinib plus trastuzumab and pertuzumabVV1 + CemiplimabEndoxifenZanidatamab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Mar 2010
Primary completion: 31 Dec 2030
Completion: 31 Dec 2031
Last update posted: 6 May 2026
Registered enrollment: 5,000
Registry id: NCT01042379

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.