A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases

Conditions

• HER-2 Positive Breast Cancer

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Everolimus — DRUG
  everolimus 5 mg PO daily as two 2.5-mg tablets
• Vinorelbine — DRUG
  vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
• Trastuzumab — DRUG
  2 mg/kg IV administered over 30 minutes weekly

Study Details

Purpose: This study is a single-arm, open-label phase II clinical trial testing the hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective, safe, and tolerable among patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases. Once enrolled, patients will receive everolimus PO daily in combination with weekly intravenous (IV) vinorelbine and trastuzumab. Cycles will be repeated every 3 weeks (21 days). At the time of progression, patients will come off study. Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has metastasized to the brain.

Key Dates

Start date

Sep 30, 2011

Status verified

Dec 2018

Primary completion

Aug 31, 2016

Completion

Oct 16, 2017

Study Design

Enrollment

32 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Everolimus +Vinorelbine + trastuzumab
  daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab

Primary Outcome Measure

Intracranial Objective Response Rate- Modified RECIST Criteria [ Time Frame: 3 years ]

Locations (4)

Find similar trials in Birmingham, AL

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