A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease or disease progression within 6 months of starting first line treatment for metastatic disease with an endocrine therapy combined with a CDK4/6 inhibitor. All patients must have historically confirmed HR positive (either estrogen receptor and/or progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0 <1+ expression, as determined by central laboratory testing results, advanced or metastatic breast cancer.
The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. 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 for advanced or metastatic breast cancer.
Has adequate tumor samples for assessment of HER2 status
Must have either:
Has protocol-defined adequate organ and bone marrow function
Key Exclusion Criteria:
CABA, 1414, Argentina
CABA, C1012AAR, Argentina
CABA, C1019ABS, Argentina
Ciudad de Buenos Aires, 1280, Argentina
Copenhagen Ø, 2100, Denmark
Plerin SUR MER, 22190, France
Marg Jaipur, 302004, India
Tricase, Lecce, 73039, Italy
Akashi-shi, 673-8558, Japan
Hidaka-shi, 350-1298, Japan
Kawasaki-shi, 216-8511, Japan
Kitaadachi-gun, 362-0806, Japan
Nishinomiya-shi, 663-8501, Japan
Osakasayama-shi, 589-8511, Japan
Sagamihara-shi, 252-0375, Japan
Shinagawa-ku, 142-8666, Japan
Shinjuku-ku, 160-0023, Japan
Alc. Cuauhtémoc, 06700, Mexico
Guadalajara Jalisco, 44280, Mexico
Guadalajra, 44260, Mexico
Sittard-Geleen, 6162 BG, Netherlands
Bukit Merah, 169610, Singapore