A phase Ib/II study investigating the combination of RAD001 with trastuzumab and paclitaxel in patients with HER2-overexpressing metastatic breast cancer.
- Conditions
- Breast cancer10027656
- Registration Number
- NL-OMON35692
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
* Patients with histologically confirmed diagnosis of metastatic breast cancer demonstrating HER2-overexpression.
* Patients must have progressive disease on therapy or within 3 months of the last trastuzumab dose for advanced disease OR recurrence within 12 months of completing trastuzumab-based therapy as (neo) adjuvant therapy.
* Patients may have received adjuvant chemotherapy and one or more prior chemotherapies for advanced disease.
* Patients receiving endocrine therapy for breast cancer < 2 weeks prior to study treatment start (endocrine therapy must have either failed in patients with hormone receptor positive disease or patients must be considered unsuitable for endocrine therapy).
* Patients who received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to study treatment start or patients who have received lapatinib < 2 weeks prior to study treatment start.
* Patients who have previously received mTOR inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the efficacy of the dose level/regimen(s) of RAD001<br /><br>recommended from the phase I with HT therapy. This will be<br /><br>based on the evaluation of overall response rate according to<br /><br>RECIST [Post-Text Supplement 1].</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate Progression Free Survival (PFS)<br /><br>To evaluate the Time To Progression (TTP)<br /><br>To evaluate overall survival (OS)<br /><br>To describe the safety profile of the studied recommended dose<br /><br>level/regimen(s)</p><br>