"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to obtain a RCB rate of 0-1 in at least 66%
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.
2 years
No
Fernando Cabanillas, MD
Principal Investigator
Auxilio Mutuo Hospital Cancer Center
United States: Food and Drug Administration
NAC CCAM 11-01
NCT01641406
March 2011
March 2013
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