DESTINY-Breast05

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Subjects with High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy

• IRAS ID

  290104

• Contact name

  Stephan Chan

• Contact email

  N/A

• Sponsor organisation

  Daiichi Sankyo Inc.

• Eudract number

  2020-003982-20

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  6 years, 9 months, 0 days

• Research summary

  The purpose of this study is to determine if trastuzumab deruxtecan (T-DXd) would be effective in the treatment of HER2-positive early breast cancer in patients that have already had treatment prior to breast cancer surgery, specifically for patients that are considered at high risk for their breast cancer to return.

  T-DXd is an approved drug for metastatic breast cancer in certain patient populations but is considered an experimental drug for your disease. T-DXd has been approved in USA and Japan for the treatment of patients with HER2-positive breast cancer that cannot be removed completely through surgery or has spread to other parts of the body (metastatic) but has not been approved for treating HER2-positive early breast cancer that can be removed by surgery. Trastuzumab emtansine (T-DM1) is the comparator drug to be used in this study.

  This study will include at least 1600 participants, in approximately 400 study sites worldwide.

  Participants be assigned randomly to the following dose groups: Group 1 (T-DXd, 5.4 mg/kg) or Group 2 (T-DM1, 3.6 mg/kg). The study is broken up into 4 main parts, a Tissue Collection Period, a Main Screening Period, a Treatment Period and a Follow-up Period.

  Participants will receive treatment every 3 weeks until disease progression or the side effects are not acceptable. The maximum duration of the study will be 10 years.

  Participants will have Follow-Up Visits 40 days after their last dose of study medicine,
  study staff will follow up every 3 months for 2 years, every 6 months for 3 to 5 years and then annually for 6 to 10 years.

  This study involves procedures including: blood, tissue and urine samples, questionnaires, vital signs (Sp02), ECG, Echo/MUGA, Physical exams, chest CT, MRI, eye tests, Disease assessment.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  21/EE/0039

• Date of REC Opinion

  8 Apr 2021

• REC opinion

  Further Information Favourable Opinion