DS8201-A-U301, Phase 3, HER2-Positive Breast cancer

• Research type

  Research Study

• Full title

  A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED STUDY OF DS-8201A, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE, VERSUS TREATMENT OF INVESTIGATOR’S CHOICE FOR HER2-POSITIVE, UNRESECTABLE AND/OR METASTATIC BREAST CANCER SUBJECTS PRETREATED WITH PRIOR STANDARD OF CARE HER2 THERAPIES, INCLUDING T-DM1

• IRAS ID

  251935

• Contact name

  Peter Schmid

• Contact email

  p.schmid@qmul.ac.uk

• Sponsor organisation

  Daiichi Sankyo, Inc

• Eudract number

  2018-000221-31

• Clinicaltrials.gov Identifier

  127553, IND

• Duration of Study in the UK

  3 years, 3 months, 1 days

• Research summary

  Breast cancer remains the most common cancer and the second leading cause of cancer mortality in women globally. In 2015, there were 2.4 million new cancer cases leading to 523,000 deaths worldwide. Approximately 20% of breast cancer cases test positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. HER2-positive breast cancers tend to be more aggressive and have worse outcomes than other types of breast cancer. This study involves research of a potential new drug, DS-8201a, that is being developed for cancer treatment. It will compare the activity of DS-8201a in participants with HER2-positive, versus 2 investigator’s choice options that are currently part of guideline recommendations for this line of therapy.
  The following drugs have been selected as the comparator treatments in this study:
  • Trastuzumab/capecitabine or
  • Lapatinib/capecitabine
  The comparator drugs are approved in the United Kingdom for HER2 positive breast cancer.
  Depending on which treatment group participants are in, they will take DS-8201a or the other treatment (trastuzumab/capecitabine or lapatinib/capecitabine).
  The study comprises of a screening part (up to 28 days), a Treatment period and a Follow-up period.
  It is expected that about 600 patients will participate in approximately 160 sites around the world. In the UK it is expected that the study will take place in 11 sites.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  18/LO/1768

• Date of REC Opinion

  7 Feb 2019

• REC opinion

  Further Information Favourable Opinion