Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica 5393212, California 5332921 and other locations
Dates
study started
study ends around

Description

Summary

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

As of June 4, 2024, this study is no longer accepting any newly screened participants.

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Keywords

Breast Cancer, Breast Neoplasms, atezolizumab, Ado-Trastuzumab Emtansine, Counterfeit Drugs, Trastuzumab, Trastuzumab Emtansine, Atezolizumab + Trastuzumab Emtansine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed invasive breast carcinoma
  • Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
  • Centrally confirmed PD-L1 and hormone receptor status
  • Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)
  • Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)
  • <=12 weeks between primary surgery and randomization
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55%
  • Life expectancy >= 6 months
  • Adequate hematologic and end organ function

You CAN'T join if...

  • Stage IV breast cancer
  • An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
  • Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
  • History of exposure to various cumulative doses of anthracyclines
  • History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)
  • Current grade >=2 peripheral neuropathy
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
  • History of or active autoimmune disease or immune deficiency
  • Treatment with immunostimulatory or immunosuppressive agents
  • Cardiopulmonary dysfunction
  • Any known active liver disease

Locations

  • UCLA Medical Center
    Santa Monica 5393212 California 5332921 90404 United States
  • Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center
    Buena 5331572 California 5332921 91505 United States
  • Innovation Clinical Research Institute
    Whittier 5409059 California 5332921 90603 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04873362
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1188 people participating
Last Updated