A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
This study will compare DS-8201a to physician choice standard treatment.
Participants must have HER2-low breast cancer that has been treated before.
Participants' cancer:
This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants.
The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.
Inclusion Criteria:
Is the age of majority in their country
Has pathologically documented breast cancer that:
Has documented radiologic progression (during or after most recent treatment)
Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
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:
Goodyear, Arizona 85338, United States
Houston, Texas 77030, United States
Plérin, Cotes d'Armor 22190, France
Brescia, 25100, Italy
Kashiwa-shi, Chiba 277-8577, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Onohigashi, Osakasayama-shi 589-8511, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Shinagawa-Ku, Tokyo-To 142-8666, Japan
Matosinhos Municipality, 4464-509, Portugal
Santa Maria da Feira, 4520-211, Portugal
Moscow, 143423, Russia
Incheon, Gyeonggi-do 22332, South Korea