A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
This study will compare DS 8201a to standard treatment.
Participants must have HER2 breast cancer that has been treated before.
Their cancer:
The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.
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 or within 6 months after completing adjuvant therapy)
Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
Has adequate hematopoietic, renal and hepatic functions
Exclusion Criteria:
Kansas City, Missouri 64132, United States
Tacoma, Washington 98405, United States
Porto Alegre, Rio Grande do Sul 90110-270, Brazil
Santo André, São Paulo 09060-650, Brazil
Plérin, Cotes d'Armor 22190, France
Bottrop, Rhineland-Palatinate 46236, Germany
Müenster, 48149, Germany
Bergamo, 24127, Italy
Osakasayama-shi, Osaka 589-8511, Japan
Ōsakasayama-shi, Osaka 589-8511, Japan
Ehime, 791-0280, Japan
Hokkaido, 003-0804, Japan
Incheon, Gyeonggi-do 22332, South Korea