Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)
Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.
Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer.
The study aims to evaluate the efficacy, and safety of trastuzumab deruxtecan, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
Key Inclusion Criteria:
Patients must be ≥18 years of age
Pathologically documented breast cancer that:
No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis.
Has protocol-defined adequate organ and bone marrow function
ECOG performance status 0 or 1
Key Exclusion Criteria:
CABA, 1414, Argentina
CABA, C1012AAR, Argentina
Caba, C1118AAT, Argentina
Capital Federal, C1417DTB, Argentina
Ciudad de Buenos Aires, 1280, Argentina
North York, Ontario M2K 1E1, Canada
Ste-Foy, Quebec G1V 4G2, Canada
Copenhagen O, 2100, Denmark
Akashi-shi, 673-8558, Japan
Hidaka-shi, 350-1298, Japan
Isehara-shi, 259-1193, Japan
Kawasaki-shi, 216-8511, Japan
Kurume-shi, 830-0011, Japan
Nishinomiya-shi, 663-8501, Japan
Ota-shi, 373-8550, Japan
Shinagawa-ku, 142-8666, Japan
Shinjuku-ku, 160-0023, Japan
Shinjuku-ku, 162-8655, Japan
Alc. Cuauhtémoc, 06700, Mexico
Cheonan-si, 31151, South Korea