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)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Alabama Oncology โ Birmingham, Alabama
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (238 Sites)
Showing the first 25 of 238 sites.
- Alabama Oncology โ Birmingham, Alabama
- Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center โ Buena, California
- UCLA Medical Center โ Santa Monica, California
- Innovation Clinical Research Institute โ Whittier, California
- Florida Cancer Specialists โ West Palm Beach, Florida
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital โ Carrollton, Georgia
- University of Iowa โ Iowa City, Iowa
- New England Cancer Specialists โ Westbrook, Maine
- The Valley Hospital โ Paramus, New Jersey
- Levine Cancer Institute โ Charlotte, North Carolina
- Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit โ Philadelphia, Pennsylvania
- The West Clinic โ Germantown, Tennessee
- Thompson Cancer Survival Center โ Knoxville, Tennessee
- Mays Cancer Center at UT Health San Antonio MD Anderson Cancer โ San Antonio, Texas
- Hematology Oncology Associates of Fredericksburg, Inc. โ Fredericksburg, Virginia
- Virginia Oncology Associates - New Port News โ Newport News, Virginia
- Virginia Oncology Associates โ Norfolk, Virginia
- Virginia Cancer Institute โ Richmond, Virginia
- Virginia Oncology Associates - Virginia Beach โ Virginia Beach, Virginia
- Providence Regional Cancer Partnership โ Everett, Washington
- Kadlec Clinic Hematology and Oncology โ Kennewick, Washington
- Northwest Medical Specialties โ Tacoma, Washington
- Macarthur Cancer Therapy Centre โ Campbelltown, New South Wales
- Royal North Shore Hospital โ St Leonards, New South Wales
- Princess Alexandra Hospital โ Woolloongabba, Queensland
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.