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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

Official Title

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

Details

An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting, and who have received at least one, and no more than three, lines of therapy in the metastatic setting.

Keywords

HER-2 Positive Breast Cancer Metastatic Neoplasm Capecitabine Gemcitabine Vinorelbine Trastuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient.Tumors may be estrogen receptor (ER)/progesterone receptor (PR) positive or negative.
  • Prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. Prior radiotherapy, hormonal therapies,and other anti-HER2 therapies are allowed.
  • Prior treatment with at least one, and no more than three, lines of therapy in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
  • Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
  • Life expectancy ≥ 12 weeks
  • Acceptable laboratory parameters
  • Women of childbearing potential must have negative pregnancy test performed within 7 days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug

You CAN'T join if...

  • Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases
  • History of uncontrolled seizures within 6 months of randomization
  • History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation
  • History of clinically significant cardiovascular disease
  • Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
  • Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapy

Locations

  • US Davis Medical Center - UC Davis Comprehensive Center accepting new patients
    Sacramento, California, 95817, USA
  • Stanford University Medical Center accepting new patients
    Stanford, California, 94305, USA
  • Kaiser Permenente Medical Center accepting new patients
    Vallejo, California, 94589, USA
  • Pacific Cancer Medical Center, Inc accepting new patients
    Anaheim, California, 92801, USA
  • East Valley Hematology And Oncology accepting new patients
    Burbank, California, 91505, USA
  • Long Beach Memorial Medical Center accepting new patients
    Long Beach, California, 90806, USA
  • Hao Wei Zhang, MD, Inc accepting new patients
    Los Angeles, California, 90033, USA
  • Sharp Memorial Hospital accepting new patients
    San Diego, California, 92123, USA
  • Central Coast Medical Oncology accepting new patients
    Santa Maria, California, 93454, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MacroGenics
ID
NCT02492711
Phase
Phase 3
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
January 2017
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