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Monoclonal Antibodies

Trastuzumab Deruxtecan for Advanced HER2 Positive Cancer

Phase 1
Waitlist Available
Led By Geraldine O'Sullivan Coyne
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured
Women of non-child-bearing potential are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1, prior to ds-8201a administration, at end of infusion, and at 5 hours post-infusion; at time of the cycle 1 day 7 biopsy; on day 1 of cycles 2, 3, and 4: prior to ds-8201a administration and at end of infusion
Awards & highlights

Study Summary

This trial is studying the effects of DS-8201a on patients with advanced HER2 positive cancer. DS-8201a works by binding to HER2 on the surface of tumor cells and damaging their DNA, resulting in tumor cell death.

Who is the study for?
This trial is for adults with advanced HER2 positive cancer, who have measurable or evaluable disease and are not responding to standard treatments. Participants must be willing to undergo biopsies, provide blood samples, and have a good performance status (able to carry out daily activities). They should not be pregnant or breastfeeding and must use contraception. People with recent major surgeries, certain heart conditions, uncontrolled infections or illnesses that could interfere with the study cannot join.Check my eligibility
What is being tested?
The trial is testing DS-8201a's biological effects on patients with advanced HER2 positive cancers. It involves examining how this drug affects protein levels and immune cells in tumors by analyzing biopsy samples before and after treatment. The study includes tests like echocardiography, MRI scans, CT scans, MUGA scans, biospecimen collection, and biopsies to monitor the drug's impact.See study design
What are the potential side effects?
DS-8201a may cause side effects such as damage to DNA leading to tumor cell death which can result in fatigue, nausea or other common chemotherapy-related symptoms. Specific side effects will vary from person to person based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but have been treated and cured.
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I am a woman who cannot become pregnant.
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I am 18 years old or older.
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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
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My hepatitis B virus is under control with treatment.
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My tumor is HER2-positive, confirmed by a certified lab.
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My liver function tests are within the required range.
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I am willing to have 3 needle biopsies for research.
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I am mostly active and can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of the treatment until disease progression/recurrence
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the treatment until disease progression/recurrence for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Early topoisomerase 1 cleavable complex (Top1cc)/deoxyribonucleic acid (DNA) damage response (DDR)
Tumor immune microenvironment response
Secondary outcome measures
Serum
Incidence of adverse events
Overall response rate
Other outcome measures
Pharmacodynamic analysis
Pharmacokinetic analysis

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (trastuzumab deruxtecan)Experimental Treatment7 Interventions
Patients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA, CT or MRI, biopsies, and collection of blood samples throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Trastuzumab Deruxtecan
2021
Completed Phase 3
~610
Biopsy
2014
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,251 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Geraldine O'Sullivan CoynePrincipal InvestigatorNational Cancer Institute LAO
4 Previous Clinical Trials
216 Total Patients Enrolled
Alice P ChenPrincipal InvestigatorNational Cancer Institute LAO
4 Previous Clinical Trials
202 Total Patients Enrolled

Media Library

Trastuzumab Deruxtecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04294628 — Phase 1
Breast Cancer Research Study Groups: Treatment (trastuzumab deruxtecan)
Breast Cancer Clinical Trial 2023: Trastuzumab Deruxtecan Highlights & Side Effects. Trial Name: NCT04294628 — Phase 1
Trastuzumab Deruxtecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294628 — Phase 1
~18 spots leftby Dec 2025
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