Clinical Trial: "Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: "Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"

Brief Summary: The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To evaluate the prognostic factors associated associated with pathological response as measured by the residual cancer burden tool.

Detailed Summary: Treatment propose of TEC-NAX for the triple negatives and for the Her2+ cases. For the Er+/Her2- cases, we propose to use the PET scan to guide therapy after the first course of TEC. Those who drop in SUV≤5%, will have their treatment modified by using the Oncotype test. Those Her2 negative patients whose response to the first 4 courses of induction TEC is less than a complete remission, will have their tretment changed to a second line regimen, Navelbine-Avastin-Xeloda(NAX), with the intention of capturing a better response prior to surgery. Those who are Her2+ will initially also receive TEC but subsequent therapy will include Trastuzumab(Herceptin) whether thet respond wellor not to TEC.
Sponsor: Auxilio Mutuo Cancer Center

Current Primary Outcome: The primary objective is to obtain a RCB rate of 0-1 in at least 66% [ Time Frame: 2 years ]

The primary objective is to raise the RCB rate of 0-1 to ≥40%. the startegy of using Oncotype test to guide NAC therapy will be considered encouraging for future testing if we are able to achieve this goal.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Auxilio Mutuo Cancer Center

Dates:
Date Received: July 11, 2012
Date Started: March 2011
Date Completion: March 2013
Last Updated: July 12, 2012
Last Verified: July 2012