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) - DESTINY-Breast06

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52479

Enrollment

Registered

2020-06-23

Start date

2021-09-16

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

breastcancer Metastatic breastcancer

Interventions

Arm A: treatment trastuzumab deruxtecan on day 1 of every 3-weekly cycle ArmB: treatment with chemotherapy of investigator's choice (capecitabine, paclitaxel or nab-paclitacel)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Key Inclusion Criteria: • Patients must be >=18 years of age. • Pathologically documented breast cancer that: 1. is advanced or metastatic 2. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3. has HER2-low or HER2 IHC >0

Exclusion criteria

Exclusion criteria: Key Exclusion Criteria: • Ineligible for all options in the investigator*s choice chemotherapy arm • Uncontrolled intercurrent illness or significant cardiovascular disease • Active or prior documented ILD/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening • Lung-specific intercurrent clinically significant illnesses • Patients with spinal cord compression or clinically central nervous system metastasis.

Design outcomes

Primary

Measure	Time frame
Assess the efficacy of trastuzumab deruxtecan compared to chemotherapy on progression free survival (PFS) of the population	—

Secondary

Measure	Time frame
Assess the efficacy of trastuzumab deruxtecan compared to chemotherapy on overall survival (OS) of the population Assess the efficacy of trastuzumab deruxtecan compared to chemotherapy on overall survival (OS) in the HER2 ICH>0	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)