A PHASE 3 MULTICENTER RANDOMIZED OPENLABEL ACTIVE-CONTROLLED TRIAL OF DS-8201A AN ANTI-HER2-ANTIBODY DRUG CONJUGATE (ADC) VERSUS TREATMENT OF PHYSICIAN S CHOICE FOR HER2LOW UNRESECTABLE AND/OR METASTATIC BREAST CANCER SUBJECTS

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Her2low, Unresectable And/or Metastatic Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    Pathologically documented breast cancer that: 1) Is Her 2-Low (Either HER 2 IHC 1+ or IHC 2+ with negative FISH) . 2) Is HR-positive 3) Has been treated with maximum of 2 prior lines of chemotherapy in the metastatic setting. 4) Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines). 5) Has measurable disease by RECSIT 6) Must have progression on last treatment 7) Unlimited number of prior hormonal therapies.

You may not be eligible for this study if the following are true:

  • 1) Has uncontrolled or significant cardiovascular disease. 2) Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 3) Has spinal cord compression or clinically active central nervous system metastases. 4) Prior treatment with any HER 2 directed drugs. 5) HER 2 IHC 0


If you are registered as a volunteer, please login to the dashboard to send referrals.