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

NCT04494425 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 866

Last updated 2026-03-04

Study results available
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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.

Conditions

  • Advanced or Metastatic Breast Cancer

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2024-03-18
Completion
2026-06-19
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04494425 on ClinicalTrials.gov