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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
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

NCT04873362

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Atezolizumab, Trastuzumab Emtansine, Placebo, Trastuzumab

Countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, China, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 (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

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
Locations (238)
  • Birmingham, Alabama, United States
  • Buena, California, United States
  • Santa Monica, California, United States
  • Whittier, California, United States
  • West Palm Beach, Florida, United States
  • Carrollton, Georgia, United States
  • Iowa City, Iowa, United States
  • Westbrook, Maine, United States
  • Paramus, New Jersey, United States
  • Charlotte, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Germantown, Tennessee, United States
  • Knoxville, Tennessee, United States
  • San Antonio, Texas, United States
  • Fredericksburg, Virginia, United States
  • Newport News, Virginia, United States
  • Norfolk, Virginia, United States
  • Richmond, Virginia, United States
  • Virginia Beach, Virginia, United States
  • Everett, Washington, United States
  • Kennewick, Washington, United States
  • Tacoma, Washington, United States
  • Campbelltown, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Woolloongabba, Queensland, Australia
  • Innsbruck, Austria
  • Linz, Austria
  • Salzburg, Austria
  • Brussels, Belgium
  • Hasselt, Belgium
  • + 208 more on CT.gov