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A Brief Dose Escalation Followed by a Phase 2 Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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.

Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast cancer, with stage IV

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension as greater than or equal to 20mm with conventional techniques
or as greater than or equal to 10mm with spiral CT scan.

- Primary tumor or metastasis must overexpress HER2

- Patient must have received 1-2 prior chemotherapeutic regiments for metastatic breast
cancer and must have been off treatment for at least three weeks.

- Patient must have received and progressed on at least 1 prior trastuzumab-containing
regimen, but not more than 2, in the metastatic setting.

- Patients may have received prior radiation therapy

- Patients may have received hormonal therapy in the adjuvant or metastatic setting

- 18 years of age or older

- Life expectancy of greater than 6 months

- Normal organ and marrow function as defined in the protocol

- Left ventricular ejection fraction (LVEF) greater than or equal to the institutional
lower limit of normal

Exclusion Criteria:

- Treatment with any investigational drug within 4 weeks

- Long-term treatment, over 3 months, with a systemic steroid or another
immunosuppressive agent

- Other malignancies within the past 3 years, except for adequately treated carcinoma
of teh cervix or basal-or squamous-cell carcinoma of the skin

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001

- An active, bleeding diathesis or an oral anti-vitamin K medication

- Prior treatment with an mTOR inhibitor

- History of non-compliance with medical regimens

- Unwillingness or inability to comply with the protocol

- Major surgery within 2 weeks before study entry

- Patients with active brain metastases or leptomeningeal carcinomatosis

- Patients who have experienced grade 1 or grade 2 hypersensitivity reactions to prior
trastuzumab therapy are eligible ONLY IF these reactions did not prevent further

- Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a
social situation that could limit their ability to comply with the study

- Pregnant or breast-feeding women

- HIV positive patients

- Known hypersensitivity to RAD001 (everolimus) or other rapamycins

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of RAD001 in combination with trastuzumab in HER2-positive metastatic breast cancer.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Gerburg Wulf, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • HER2 positive
  • metastatic breast cancer
  • RAD001
  • Herceptin
  • Breast Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115