NL-OMON35692CompletedPhase 2
A phase Ib/II study investigating the combination of RAD001 with trastuzumab and paclitaxel in patients with HER2-overexpressing metastatic breast cancer. - HER2+ MBC, RAD001 + trastuzumab+ paclitaxel.
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- ovartis
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •* 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.
Exclusion Criteria
- •* 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.
Investigators
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