Loading clinical trials...

COMPLETEDPHASE2

Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases

Phase II Study of Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

NCT04752059•Medical University of Vienna

View on ClinicalTrials.gov

Summary

Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases

Detailed Description

T-DXd will be administered at a dose of 5.4 mg/kg body weight once every three weeks in patients with newly diagnosed or progressive HER2 positive breast cancer brain metastases. Response rate by RANO-BM is defined the primary study endpoint.

Eligibility

Age

18 - 100 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed breast cancer
•Radiologically documented metastatic disease
•HER2-positive as defined by IHC 3+ and/or HER2/neu gene amplification
•Newly diagnosed brain metastases or brain metastases progressing after prior local therapy
•Measurable disease (RANO-BM criteria)
•No indication for immediate local treatment
•No indication of leptomeningeal disease
•KPS \>70%, ECOG \<2
•Indication for systemic anti-HER2 treatment
•Prior exposure to trastuzumab and pertuzumab
+10 more criteria

Exclusion Criteria

•Metastatic breast cancer other than HER2-positve disease
•Use of any investigational agent within 28 days prior to initiation of treatment
•History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years including contralateral breast cancer
•Major surgery, other than diagnostic surgery, within the last 4 weeks
•Indication for immediate local therapy as defined by local standard
•Leptomeningeal involvement
•Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment
•Concomitant radiotherapy
•Prior radiotherapy to the thorax other than breast irradiation or irradiation of bone metastases
•A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), left ventricular ejection fraction \<50%, arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval \>450 ms)
+13 more criteria

Locations (1)

AKH Universitaetsklinikum Vienna, Department f. Internal medicine I, oncology

Vienna, Austria

Key Dates

Start Date

July 28, 2020

Primary Completion Date

May 1, 2023

Completion Date

May 1, 2023

Last Updated

May 12, 2023

Enrollment

ACTUAL participants

Conditions

Breast Cancer Stage IV

Interventions

Trastuzumab deruxtecan

DRUG

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

NCT06064812

Metastatic Breast CancerLocally Advanced Breast Cancer+2 more

View study

COMPLETEDNA

Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients

NCT05837533

Breast Cancer Stage IVBreast Cancer Metastatic+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases

Inclusion Criteria

Exclusion Criteria

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients

Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer

Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study

Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients

Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells