Cancer

Recruiting

Baptist Health Lexington

Shelby Gambrell

Principal Investigator

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Overview

Destiny 11: A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)
Description
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
Learn more at clinicaltrials.gov
Eligibility Criteria

Inclusion

  • Patients must be at least 18 years of age.
  • Histologically documented HER2-positive early breast cancer (EBC) participants, including clinical stage at presentation (based on mammogram or breast MRI assessment): T0-4 (inclusive of inflammatory breast cancer), N1-3, M0 or ≥ T3, N0, M0 as determined by the AJCC staging system, 8th edition
  • ECOG performance status of 0 or 1 at randomization

Exclusion

  • prior history of invasive breast cancer
  • stage IV breast cancer (determined by AJCC staging system)
  • any primary malignancy within 3 years (except resected non-melanoma skin cancer, curatively treated in situ disease)
  • history of DCIS (except those treated with mastectomy >5 years prior to current diagnosis)
  • History of, or current, ILD/pneumonitis
  • Prior systemic therapy for the treatment of breast cancer
  • Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy