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8110 Gatehouse Road, Falls Church, VA 22042

A phase III, randomised, double-blind, placebo-controlled, multicentre study of the efficacy and safety of atezolizumab plus chemotherapy for patients with early relapsing recurrent (inoperable locally advanced or metastatic) triple-negative breast cancer

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03371017

Background Information

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

Offered At

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

Eligibility Information

  • Histologically confirmed triple negative breast cancer (TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
  • Documented disease progression occurring within 12 months from the last treatment with curative intent
  • Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted
  • Additional eligibility in protocol

Ineligibility Information

  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation.
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Symptomatic or rapid visceral progression
  • No prior treatment with an anthracycline and taxane
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled tumour-related pain
  • Additional ineligibility in protocol

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03371017