Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator’s Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer - DB-06

Study identifier:D9670C00001

ClinicalTrials.gov identifier:NCT04494425

EudraCT identifier:2019-004493-26

CTIS identifier:N/A

Recruitment Complete

Official Title

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)

Medical condition

advanced or metastatic breast cancer

Phase

Phase 3

Healthy volunteers

Study drug

Trastuzumab deruxtecan, Capecitabine, Paclitaxel, Nab-Paclitaxel

Sex

All

Actual Enrollment

866

Study type

Interventional

Age

18 Years - 105 Years

Date

Study Start Date: 24 Jul 2020

Primary Completion Date: 18 Mar 2024

Estimated Study Completion Date: 19 Jun 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Inclusion and exclusion criteria

Inclusion Criteria

• Patients must be ≥18 years of age
• Pathologically documented breast cancer that:
a. is advanced or metastatic
b. 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)
c. has HER2-low or HER2 IHC >0 <1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting
d. was never previously HER2-positive
e. is documented HR+ disease in the metastatic setting.
• No prior chemotherapy for advanced or metastatic breast cancer.
• Has adequate tumor samples for assessment of HER2 status
• Must have either:
a. disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor
or
b. disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting.
• Has protocol-defined adequate organ and bone marrow function

Exclusion Criteria

• Ineligible for all options in the investigator’s choice chemotherapy arm
• Lung-specific intercurrent clinically significant illnesses
• Uncontrolled or significant cardiovascular disease or infection
• Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening.
• Patients with spinal cord compression or clinically active central nervous system metastases
• Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
• Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)

No locations available

Arms	Assigned Interventions
Experimental: Trastuzumab deruxtecan Trastuzumab deruxtecan (T-DXd; DS-8201a) arm	Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a; T-DXd
Active Comparator: Standard of Care Investigator’s choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm	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

Documents available

AZ Breast Cancer Study Navigators
Download
Daiichi Sankyo Contact for Clinical Trial Information Phone: 908-992-6400
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

AZ Breast Cancer Study Navigators

+1-877-400-4656