RECRUITING

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

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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 CancerI-SPY TrialsQuantum Leap Healthcare CollaborativeQLHCI-SPYI-SPY2I-SPY1PRE-ISPYPRE-I-SPYI-SPY Phase 1I-SPY Phase 1bI-SPY-P1ISPYISPYP1I-SPY Phase 1 PlatformISPY2ISPY1Phase 1 PlatformPhase 1 Oncology PlatformT-DXd naivePRE1PRE2PRE3

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-12-22
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05868226

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Smita M Asare
CONTACT
(855) 866-0505
smita.asare@quantumleaphealth.org
Maria Pitsiouni, PhD
CONTACT
(415) 651-8047
m.pitsiouni@quantumleaphealth.org

Principal Investigator

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

Study Locations (Sites)

The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
Birmingham, Alabama, 35233
United States
The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
UChicago Medicine Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451
United States
UChicago Medicine Orland Park
Orland Park, Illinois, 60462
United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: QuantumLeap Healthcare Collaborative

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2022-12-22
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • I-SPY Trials
  • Quantum Leap Healthcare Collaborative
  • QLHC
  • I-SPY
  • I-SPY2
  • I-SPY1
  • PRE-ISPY
  • PRE-I-SPY
  • I-SPY Phase 1
  • I-SPY Phase 1b
  • I-SPY-P1
  • ISPY
  • ISPYP1
  • I-SPY Phase 1 Platform
  • ISPY2
  • ISPY1
  • Phase 1 Platform
  • Phase 1 Oncology Platform
  • T-DXd naive
  • PRE1
  • PRE2
  • PRE3

Additional Relevant MeSH Terms

  • HER2-positive Breast Cancer
  • Metastatic Cancer
  • Metastatic Breast Cancer
  • Metastatic
  • HER2-positive Metastatic Breast Cancer
  • HER2 Mutation-Related Tumors
  • HER-2 Protein Overexpression
  • HER2-negative Breast Cancer
  • Triple Negative Breast Cancer
  • HR Positive
  • Hormone Receptor-positive Breast Cancer
  • Estrogen Receptor Positive Tumor
  • Progesterone Receptor-positive Breast Cancer
  • Hormone Receptor Negative Breast Carcinoma
  • Solid Tumor
  • Solid Tumor, Adult
  • Solid Carcinoma
  • HER2 Low Breast Cancer
  • HER2 Low Breast Carcinoma
  • ER Positive Breast Cancer
  • PR-positive Breast Cancer