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A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

NCT04556773 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-12-17

No results posted yet for this study

Summary

DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer

Conditions

Interventions

DRUG

Trastuzumab deruxtecan

T-DXd: administered as an IV infusion

DRUG

Durvalumab

Durvalumab: administered as an IV infusion

DRUG

Paclitaxel

Paclitaxel: administered as an IV infusion

DRUG

Capivasertib

Capivasertib: administered orally

DRUG

Anastrozole

Anastrozole: administered orally

DRUG

Fulvestrant

Fulvestrant: administered as an IM injection

DRUG

Capecitabine

Capecitabine: administered orally

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    collaborator INDUSTRY

  • Daiichi Sankyo Company, Limited

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Komal Jhaveri, MD, FACP · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2023-08-16
Completion
2026-06-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • France
  • Mexico
  • Russia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04556773 on ClinicalTrials.gov