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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516653-44-00

Acronym

D9670C00001

Enrollment

250

Registered

2024-09-04

Start date

2020-11-30

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-Low, Hormone Receptor Positive Breast Cancer which has Progressed on Endocrine Therapy in the Metastatic Setting.

Brief summary

PFS by BICR according to RECIST 1.1 in the HR+, HER2-low population

Detailed description

Overall Survival (OS) - in HR+ HER2-low population, Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2 IHC >0 <1+ and HER2-low), OS - in ITT population (HER2 IHC >0 <1+ and HER2-low), Objective Response Rate (ORR) and Duration of response (DoR) - in HR+, HER-2 low population, PFS by Investigator assessment - in the HR+, HER2-low population, ORR and DoR - in the ITT population, PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population, Safety and tolerability of T-DXd compared to chemotherapy, The pharmacokinetics (PK) of T-Dxd, Health-related quality of life, Immunogenicity of T-Dxd

Interventions

DRUGCAPECITABINE

DRUGPACLITAXEL

DRUGDS-8201a

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS by BICR according to RECIST 1.1 in the HR+, HER2-low population	—

Secondary

Measure	Time frame
Overall Survival (OS) - in HR+ HER2-low population, Progression Free Survival (PFS) - in intent to treat (ITT) population (HER2 IHC >0 <1+ and HER2-low), OS - in ITT population (HER2 IHC >0 <1+ and HER2-low), Objective Response Rate (ORR) and Duration of response (DoR) - in HR+, HER-2 low population, PFS by Investigator assessment - in the HR+, HER2-low population, ORR and DoR - in the ITT population, PFS2 by Investigator assessment, time to first subsequent therapy (TFST) and time to second subsequent treatment or death (TSST) - in HR+, HER2-low and the ITT population, Safety and tolerability of T-DXd compared to chemotherapy, The pharmacokinetics (PK) of T-Dxd, Health-related quality of life, Immunogenicity of T-Dxd	—

Measure

Time frame

—

Countries

Austria, Belgium, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026