A Study to Look at the Combination of Chemotherapy, Trastuzumab and RAD001 in 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Neoadjuvant Study of RAD001 (Everolimus) in Combination With Paclitaxel and Trastuzumab For Operable HER2 Positive Breast Cancer|
- assess complete response rate [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]To assess the pathological complete response rate (pCR) with of 4 cycles of neoadjuvant Herceptin plus Paclitaxel and Everolimus in patients with operable HER-2 positive breast cancer.
- assess objective/radiological response rate and tolerability [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]The secondary outcome is to assess the objective/radiological response rate and to assess tolerability of the proposed treatment regimen
|Study Start Date:||July 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: paclitaxel, trastuzumab and everolimus||
80mg/m2 IV TRO 3 hours every 28 days for 4 cycles
4mg/kg IV load dose (TRO 90) minutes followed by 2 mg/kg TRO 60 minutes every week for 18 weeks
Everolimus: 10mg PO daily 16-18 weeks
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.