A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

Key facts

Study ID

NCT04739761

Run by

AstraZeneca

People needed

506

Starts

2021-06-22

Expected to finish

2027-05-26

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Known or suspected leptomeningeal disease
• Prior exposure to tucatinib treatment
• Refractory nausea and vomiting, chronic gastrointestinal disease, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of T-DXd
• History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence
• Based on screening contrast brain MRI/CT scan, participants must not have any of the following: any untreated brain lesions > 2.0 cm in size; ongoing use of systemic corticosteroids for control of symptoms of BMs; any brain lesion thought to require immediate local therapy; have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to BMs not withstanding CNS-directed therapy
• Has spinal cord compression
• Known active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. Participants with past or resolved hepatitis B virus infection are eligible, if negative for hepatitis B surface antigen and positive for anti-hepatitis B core antigen
• Participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
• Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
• Receipt of live, attenuated vaccine within 30 days prior to the first dose of T-DXd
• Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (New York Heart Association Class II to IV)
• History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
• Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue or inflammatory disorders
• Prior exposure, without adequate treatment washout period before the day of first dosing, to chloroquine/hydroxychloroquine: < 14 days
• Anticancer chemotherapy: immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy: < 3 weeks
• < 6 weeks for nitrosoureas or mitomycin
• Antibody-based anticancer therapy: < 4 weeks
• Any concurrent anticancer treatment. Concurrent use of hormonal therapy for noncancer- related conditions is allowed
• Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline
• Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation, radiation to the chest, or to more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
• Participants with prior exposure to immunosuppressive medication within 14 days prior to first study dose
• Participants with a known hypersensitivity to study intervention or any of the excipients of the product or other monoclonal antibodies

Where it is running

• Research Site — Durham, North Carolina, United States
• Research Site — Adelaide, Australia
• Research Site — Auchenflower, Australia
• Research Site — Clayton, Australia
• Research Site — Heidelberg, Australia
• Research Site — St Leonards, Australia
• Research Site — Subiaco, Australia
• Research Site — Anderlecht, Belgium
• Research Site — Bruges, Belgium
• Research Site — Leuven, Belgium
• Research Site — Liège, Belgium
• Research Site — Vancouver, British Columbia, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Copenhagen, Denmark
• Research Site — Herlev, Denmark
• Research Site — Odense C, Denmark
• Research Site — Helsinki, Finland
• Research Site — Tampere, Finland
• Research Site — Turku, Finland
• Research Site — Berlin, Germany
• Research Site — Dresden, Germany
• Research Site — Erlangen, Germany
• Research Site — Essen, Germany
• Research Site — Frankfurt, Germany
• Research Site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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