Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

Official Title

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)

Summary:

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.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment

• Progression Free Survival (PFS) by Investigator assessment
• Overall Survival (OS)
• Objective Response Rate (ORR) by BICR and Investigator assessment
• Duration of Response (DoR) by BICR and Investigator Assessment
• Time to second progression or death (PFS2) by Investigator assessment
• Health related quality of life (HRQoL) using the EORTC QLQ-C30
• Time to deterioration in EORTC-QLQ-C30 scores
• Health related quality of life (HRQoL) using the EORTC QLQ-BR45
• Serum concentration of trastuzumab deruxtecan and pertuzumab
• Immunogenicity of trastuzumab deruxtecan, alone or with pertuzumab.
• Safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab

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.

View this trial on ClinicalTrials.gov