Breast Cancer Clinical Trial
Official title:
A Phase II Neoadjuvant Study of RAD001 (Everolimus) in Combination With Paclitaxel and Trastuzumab For Operable HER2 Positive Breast Cancer
The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients.
This is an open-label Phase 2 neoadjuvant study for patients with histologically confirmed,
HER-2 positive operable breast cancer. All patients will receive 18 weeks of neoadjuvant
treatment.
The trial has an initial 2 week "biomarker lead in" phase. During this two week phase
patients will either receive Trastuzumab alone or Trastuzumab + Everolimus. This two week
lead in phase will be randomized open label. The rest of the 16 weeks of the neoadjuvant
trial treatment is non randomized open label.
For the first two weeks of neoadjuvant treatment the eligible subjects will be randomly
assigned to either receive or not receive Everolimus. This assignment will be accomplished
by a previously prepared schedule (maintained by the investigational pharmacy), such that
investigators are unaware of assignment until after the subject has been enrolled on the
study and received assignment of Everolimus or not.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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