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-   -   Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Br (https://her2support.org/vbulletin/showthread.php?t=59074)

'lizbeth 09-21-2013 12:06 PM

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:
  • Change in SUV on FDG PET [ Time Frame: 3 months ] [ Designated as safety issue: No ]To correlate baseline and change (day 15) in SUV on FDG PET with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab



Secondary Outcome Measures:
  • Change in ptDNA with response [ Time Frame: 3 months ] [ Designated as safety issue: No ]To correlate PIK3CA mutation status and other genomic alterations (mutations/somatic rearrangements) qualitatively and quantitatively in plasma tumor DNA (ptDNA) with pCR

  • Change in PI3K pathway activation with response [ Time Frame: 3 months ] [ Designated as safety issue: No ]To correlate PI3K pathway activation (e.g. PTEN low and/or PIK3CA mutation, HER 1-4 expression and/or phosphorylation) in tumor samples and pCR

  • Changes in Ki67 with response [ Time Frame: 3 months ] [ Designated as safety issue: No ]To correlate baseline and change (day 15) in Ki67 with pCR



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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