A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

  • STATUS
    Recruiting
  • End date
    Oct 26, 2034
  • participants needed
    1700
  • sponsor
    Hoffmann-La Roche
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Updated on 5 October 2021
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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.

Details
Condition Breast Cancer
Age 18years - 100years
Treatment Placebo, Atezolizumab, Trastuzumab, Trastuzumab Emtansine
Clinical Study IdentifierNCT04873362
SponsorHoffmann-La Roche
Last Modified on5 October 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

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: 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

Exclusion Criteria

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
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