Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in high risk HER2-positive patients with residual invasive breast cancer following neoadjuvant therapy

B-60 DESTINY-Breast05 (D8201-A-U305)
Breast Cancer
Joseph Kash, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.

Sponsor: NSABP FDN

https://clinicaltrials.gov/ct2/show/NCT04622319

 

  • HER2-positive invasive breast carcinoma
  • Clinical stage: T1-4, N0-3, M0; patients presenting with T1N0 tumors are not eligible
  • Completion of at least 6 cycles of pre-op chemo, including  at least 9 weeks of trastuzumab and at least 9 weeks of  taxane-based chemo 
  • Residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of pre-op treatment
  • Less than 12 weeks sincesurgery
  • No stage IV (metastatic) breast cancer
  • No history of certain other malignancies within the last 5 years or myocardial infarction within 6 months
  • No current or history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids 
  • No known pulmonary compromise; any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement 
 
Up to 10 years
Pending IRB Approval for Recruiting
Interventional
III
Sofia Mikac, BSN
630-646-6073
630-646-6074
630-646-6072