NCT01042379 (I-SPY 2 Trial) (Clinical Trial)

Study Title
I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (NCT01042379)

Trial Description
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.

This trial is sponsored by QuantumLeap Healthcare Collaborative. [1]

Study Data

• Condition:
  • Breast Neoplasms
  • Breast Cancer
  • Breast Tumors
• Interventions:
  • Drugs used in this trial
    • Standard Therapy
    • AMG 386 (with or without Trastuzumab; Herceptin®;Genentech)
    • AMG 479 (Ganitumab) plus Metformin (Glumetza®; Salix Pharmaceuticals Inc.)
    • MK-2206 with or without Trastuzumab (Herceptin®;Genentech)
    • Ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech) and Pertuzumab (Perjeta®; Genentech, Inc.)
    • Pertuzumab and Trastuzumab
    • Ganetespib
    • ABT-888
    • Neratinib
    • PLX3397
    • Pembrolizumab
    • Talazoparib plus Irinotecan
    • Patritumab and Trastuzumab
    • SGN-LIV1A

• Phase: II
• Estimated Enrollment: 1,200
• Start: March 2010
• Estimated Primary Completion: December 2018 (Final data collection date for primary outcome measure)
• Last verified: December 7, 2016

Study Schematic

(Coming soon)

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Last Editorial review: October 11, 2017
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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