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.
Administered by intravenous infusion
Administered by intravenous infusion
Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Buenos Aires, Argentina
CABA, Argentina
CABA, Argentina
Caba, Argentina
Capital Federal, Argentina
Cipolletti, Argentina
Ciudad de Buenos Aires, Argentina
La Plata, Argentina
Mar del Plata, Argentina
Rosario, Argentina
Rosario, Argentina
San Salvador de Jujuy, Argentina