Phase 2
Completed N=11
Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00458237 ↗Enrolled (actual)
11
Serious AEs
45.5%
Results posted
Mar 2016
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — 0; 0 participants with DLT
Summary
The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in combination with trastuzumab. RAD001 has been used in patients with severe rheumatoid arthritis, in recipients of solid-organ transplants, healthy volunteers and experiments with animals, and information from those other research studies suggest that this RAD001 may help to stop cancer cells from growing abnormally.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
0; 0 | — |
| SECONDARY Clinical Response Rate |
.67; .80 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed invasive breast cancer, with stage IV disease
- 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 administration
- Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a social situation that could limit their ability to comply with the study requirements.
- Pregnant or breast-feeding women
- HIV positive patients
- Known hypersensitivity to RAD001 (everolimus) or other rapamycins
Data sourced from ClinicalTrials.gov (NCT00458237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.