A Brief Dose Escalation Followed by a Phase 2 Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
- Since we are looking for the dose of RAD001 that can be given safely in combination
with trastuzumab, not everyone will receive the same amount of RAD001. Small groups of
participants will be enrolled at a certain dose of RAD001 and if they tolerate the
medications well, the next small group will receive a higher dose. This will continue
until the optimal dose of RAD001 that can be given in combination with trastuzumab is
- Participants will receive trastuzumab through an IV once every three weeks and will
take RAD001 by mouth daily. This three week regimen is called a cycle. A study diary
will be provided to record the doses of RAD001 that the participant takes.
- During all treatment cycles, participants will have a physical exam and be asked
questions about their general health including specific questions about any side
effects they may be experiencing. They will need to come to the clinic weekly during
the first cycle, then every cycle for the remainder of the study.
- Every 9 weeks (3 cycles) the tumor will be reassessed with a MUGA or MRI scan. After
the first 3 cycles a MUGA scan or echocardiogram will be repeated. It there are
abnormalities, the test will be repeated more often.
- Blood work will be drawn on days 1, 2, 8, and 15 of the first cycle of treatment and
then once at every restaging (every 4 cycles).
- There is an optional tissue biopsy component to this study. We will ask permission to
perform 2 biopsies. The first biopsy will be performed before the participant starts
receiving the study treatment and the second will be performed after the first cycle of
- We will keep track of the participants medical condition for the next three years by
calling them on the telephone twice a year to see how they are doing.
- Participants may remain on the study treatment as long as their cancer does not
progress and they are not experiencing any harmful side effects from the treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and tolerability of RAD001 in combination with trastuzumab in HER2-positive metastatic breast cancer.
Gerburg Wulf, MD, PhD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|