NCT04494425

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 866 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	Trastuzumab deruxtecan by intravenous infusion
DRUG	Capecitabine	Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
DRUG	Paclitaxel	Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
DRUG	Nab-Paclitaxel	Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion

Timeline

• Start date: 2020-07-24
• Primary completion: 2024-03-18
• Completion: 2026-06-19
• First posted: 2020-07-31
• Last updated: 2026-03-04
• Results posted: 2025-04-02

Locations

293 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study