Breast

General Information



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 (IMpassion 132)
Adult
NCT03371017
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).
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

Contact Information


Inova Breast Cancer Research Team


571-472-0629

breastcancerresearch@inova.org

Additional Information can be found at https://clinicaltrials.gov/ct2/show/NCT03371017.