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Clinical Trials/NL-OMON35692
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.

ovartis0 sites5 target enrollmentStarted: TBDLast updated:
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

Sponsor
ovartis

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