DS8201-A-U303: A Phase III, multicenter, randomized, open-label, active-controlled trial of DS-8201a, an anti-HER2-antobody drug conjugate (ADC), versus treatment of physician’s choice for HER2low, unresectable and/or metastatic breast cancer subjects
Indication :

Cancer du sein, HER2 faible, inopérable et/ou métastatique

Sponsor :

Daiichi Sankyo

Phase :


Ligne :

2ème ou 3ème

Traitement :

Trastuzumab Deruxtecan versus physician's choice

Spécificités :
  • HER2-low
  • unresectable and/or metastatic cancer

Site :


Contact(s) :
Khalil Zaman
Principal Investigator

DO - Service d'Oncologie Médicale

Rue du Bugnon 46

021 314 79 05

Primary objective :

To compare the progression-free survival (PFS) benefit of DS-8201a to physician’s choice in HER2-low, hormone receptor (HR)-positive breast cancer, based on blinded independent central review (BICR)

Inclusion criteria :
  1. Is the age of majority in their country
  2. Has pathologically documented breast cancer that:
    • Is unresectable or metastatic
    • Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
    • Is HR-positive or HR-negative
    • Has progressed on, and would no longer benefit from, endocrine therapy
    • Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the metastatic setting
    • 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)
  3. Has documented radiologic progression (during or after most recent treatment)
  4. Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
    • assessment of HER2 status
    • assessment of post-treatment status
  5. Has at least 1 protocol-defined measurable lesion
  6. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
  7. Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)

Exclusion criteria :
  1. Is ineligible for all options in the physician's choice arm
  2. Has breast cancer ever assessed with high-HER2 expression
  3. Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
  4. Has uncontrolled or significant cardiovascular disease
  5. Has spinal cord compression or clinically active central nervous system metastases
  6. 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
  7. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study