Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Br
Wow, a future study without chemo? Still pending, but one to watch!
ClinicalTrials.gov Identifier: NCT01937117 This study is not yet open for participant recruitment. Verified September 2013 by Sidney Kimmel Comprehensive Cancer Center Sponsor: Sidney Kimmel Comprehensive Cancer Center Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center ClinicalTrials.gov Identifier: NCT01937117 First received: September 3, 2013 Last updated: September 11, 2013 Last verified: September 2013 History of Changes
http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Purpose This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery. Condition Intervention Phase Breast Cancer Procedure: Positron emission tomography (PET) Drug: Trastuzumab Drug: Pertuzumab Phase 2 Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value (SUV) on Positron Emission Tomography (PET) With Pathological Complete Response (pCR) to Pertuzumab and Trastuzumab in Patients With Primary Operable HER2-Positive Breast Cancer Resource links provided by NLM: Genetics Home Reference related topics: breast cancer MedlinePlus related topics: Breast Cancer Cancer Drug Information available for: Trastuzumab Pertuzumab U.S. FDA Resources Further study details as provided by Sidney Kimmel Comprehensive Cancer Center: Primary Outcome Measures:
Secondary Outcome Measures:
Estimated Enrollment: 88 Study Start Date: September 2013 Estimated Study Completion Date: December 2016 Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)http://www.clinicaltrials.gov/ct2/sh...erjeta&rank=20 |
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