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PRE-I-SPY Phase I/Ib Oncology Platform Program

Description

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

Conditions

HER2-positive Breast CancerMetastatic CancerMetastatic Breast CancerMetastaticHER2-positive Metastatic Breast CancerHER2 Mutation-Related TumorsHER-2 Protein OverexpressionHER2-negative Breast CancerTriple Negative Breast CancerHR PositiveHormone Receptor-positive Breast CancerEstrogen Receptor Positive TumorProgesterone Receptor-positive Breast CancerHormone Receptor Negative Breast CarcinomaSolid TumorSolid Tumor, AdultSolid CarcinomaHER2 Low Breast CancerHER2 Low Breast CarcinomaER Positive Breast CancerPR-positive Breast Cancer
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Related Conditions:

HER2-positive Breast CancerMetastatic CancerMetastatic Breast CancerMetastaticHER2-positive Metastatic Breast CancerHER2 Mutation-Related TumorsHER-2 Protein OverexpressionHER2-negative Breast CancerTriple Negative Breast CancerHR PositiveHormone Receptor-positive Breast CancerEstrogen Receptor Positive TumorProgesterone Receptor-positive Breast CancerHormone Receptor Negative Breast CarcinomaSolid TumorSolid Tumor, AdultSolid CarcinomaHER2 Low Breast CancerHER2 Low Breast CarcinomaER Positive Breast CancerPR-positive Breast Cancer

Study Overview

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Study Details

Study overview

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

PRE-I-SPY Phase I/Ib Oncology Platform Program

Condition
HER2-positive Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center, Birmingham, Alabama, United States, 35233

Chicago

The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States, 60637

New Lenox

UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital, New Lenox, Illinois, United States, 60451

Orland Park

UChicago Medicine Orland Park, Orland Park, Illinois, United States, 60462

Minneapolis

University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States, 55455

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    QuantumLeap Healthcare Collaborative,

    Paula R Pohlmann, MD, MSc, PhD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

    Study Record Dates

    2027-12-30