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A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NRG-BR004)

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03199885

Background Information

The purpose of this study is to help determine if HER-2 positive, metastatic breast cancer can be stabilized and life with the disease be extended by adding a new drug to the standard treatment regimen

For more information go to https://clinicaltrials.gov/ct2/show/NCT03199885

Offered At

Inova Schar Cancer Institute
A department of Inova Fairfax Hospital
8081 Innovation Park Drive
Fairfax, VA 22031

And:

Inova Schar Cancer Institute
3580 Joseph Siewick Drive, Suite 403
Fairfax, VA 22033

Eligibility Information

  • Male or female over 18 years of age
  • Documented classification of HER-2 positive, metastatic breast cancer
  • Adequate hematologic, hepatic, and renal function
  • Additional eligibility in protocol

Ineligibility Information

  • Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases (some exceptions detailed in protocol)
  • Known leptomeningeal carcinomatosis
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
  • Active cardiac disease
  • History of systemic anti-cancer therapies (specific exclusions in protocol)
  • Patients with clinically active tuberculosis
  • Additional ineligibility in protocol

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03199885