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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

Status
Closed
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04873362
Protocol IDs
WO42633 (primary)
2020-003681-40
NCI-2021-04294
Study Sponsor
Hoffmann-La Roche

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.

Eligibility

  1. Histologically confirmed invasive breast carcinoma
  2. Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
  3. Centrally confirmed PD-L1 and hormone receptor status
  4. 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)
  5. 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)
  6. <=12 weeks between primary surgery and randomization
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  8. 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%
  9. Life expectancy >= 6 months
  10. Adequate hematologic and end organ function

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 101 and Suite 102
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.