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Intrathecal Pertuzumab and Trastuzumab in Patients With New Untreated Asymptomatic or Low Symptomatic Brain Metastasis in HER2 Positive Breast Cancer

NCT02598427 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-02-28

No results posted yet for this study

Summary

The purpose of this research study is to determine how well pertuzumab and trastuzumab works in treating breast cancer that has spread to the brain. Pertuzumab and trastuzumab are treatments that stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).

Pertuzumab and trastuzumab have been found to be very effective for HER2-positive breast cancer and are FDA approved for treatment of metastatic breast cancer outside of the brain when given through the vein. This suggests that pertuzumab and trastuzumab may help shrink or stabilize HER2-positive breast cancer that has spread to the brain in this research study.

In this research study, the investigators are looking to see whether pertuzumab and trastuzumab will work to decrease the size of or stabilize breast cancer that has spread to the brain.

Conditions

  • HER2 Positive Untreated Metastatic Breast Cancer
  • Asymptomatic or Low Symptomatic Brain Metastasis in Breast Cancer

Interventions

DRUG

Pertuzumab

Pertuzumab will be administered intrathecally via a lumber puncture. The dosing cohorts are described above in the arm description.

DRUG

Trastuzumab

Trastuzumab will be administered intrathecally via a lumber puncture. The dosing cohorts are described above in the arm description.

Sponsors & Collaborators

  • Kimberly Blackwell

    lead OTHER

Principal Investigators

  • Kimberly Blackwell, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-02-22
Completion
2018-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02598427 on ClinicalTrials.gov