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Monoclonal Antibodies

Trastuzumab Deruxtecan for Metastatic Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
Has adequate archival tumor samples available or is willing to provide fresh biopsies prior to randomization for assessment of HER2 status and post-treatment status
Must not have
Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
Has spinal cord compression or clinically active central nervous system metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening and every 6 weeks up to withdrawal of subject consent, progressive disease (pd), or unacceptable toxicity, up to approximately 3 years
Awards & highlights

Summary

This trial will compare trastuzumab deruxtecan to other treatments for patients with HER2-low breast cancer that cannot be removed by surgery and has spread. The treatment targets and kills cancer cells by delivering chemotherapy directly to them. Trastuzumab deruxtecan has shown effectiveness in patients with HER2-low breast cancer, resulting in longer periods without the disease getting worse and longer life expectancy compared to other chemotherapy treatments.

Who is the study for?
This trial is for adults with HER2-low breast cancer that's inoperable or has spread, and who have tried endocrine therapy without success. They should have had 1-2 prior chemotherapy treatments in the metastatic setting, be able to provide tumor samples, and not have high-HER2 cancer or a history of certain lung conditions.
What is being tested?
The study compares DS-8201a (Trastuzumab Deruxtecan) with standard treatments chosen by physicians such as Eribulin, Paclitaxel, Gemcitabine, Capecitabine or Nab-paclitaxel. Participants will receive either the new drug or one of these existing drugs based on their doctor's choice.
What are the potential side effects?
Possible side effects include allergic reactions to medication components, fatigue, nausea and vomiting from chemotherapy drugs. Trastuzumab Deruxtecan may cause issues like hair loss and low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has low levels of HER2.
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I can provide samples of my tumor for testing before treatment starts.
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My cancer has grown or spread on my latest scans.
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My breast cancer cannot be surgically removed or has spread.
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I am legally considered an adult in my country.
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My condition worsened despite hormone therapy.
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My heart, liver, kidneys, bone marrow, and blood clotting functions are all within normal ranges.
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My cancer was never previously tested positive for HER2.
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I've had 1-2 rounds of chemotherapy for my cancer after it came back or spread.
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My cancer is either hormone receptor positive or negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a HER2-targeting therapy before.
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I have spinal cord compression or active brain metastases.
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My breast cancer has high levels of HER2.
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I have serious heart problems that are not under control.
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I cannot receive any standard treatments my doctor would normally choose.
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I have or had lung inflammation that needed steroids, or it's suspected but not confirmed by scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening and every 6 weeks up to withdrawal of subject consent, progressive disease (pd), or unacceptable toxicity, up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening and every 6 weeks up to withdrawal of subject consent, progressive disease (pd), or unacceptable toxicity, up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Secondary study objectives
Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)
Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
+6 more
Other study objectives
All-Cause Mortality

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Trastuzumab deruxtecanExperimental Treatment1 Intervention
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a
Group II: Physician's ChoiceActive Control5 Interventions
HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: * Capecitabine * Eribulin * Gemcitabine * Paclitaxel * Nab-paclitaxel

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Antibody-drug conjugates (ADCs) like Trastuzumab Deruxtecan target the HER2 receptor on breast cancer cells, combining the specificity of monoclonal antibodies with the cytotoxic potency of chemotherapy. These drugs bind to HER2, delivering a cytotoxic agent directly to the tumor, which enhances treatment efficacy and minimizes damage to healthy cells. This targeted approach is crucial for breast cancer patients as it improves outcomes and reduces systemic side effects. Other treatments, such as trastuzumab and pertuzumab, also target HER2, blocking its signaling pathways and inhibiting tumor growth. Understanding these mechanisms allows for personalized treatment plans, optimizing efficacy and side effect management.
Aiming at a Tailored Cure for ERBB2-Positive Metastatic Breast Cancer: A Review.Promising novel therapies for the treatment of endometrial cancer.

Find a Location

Who is running the clinical trial?

Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
48,651 Total Patients Enrolled
3 Trials studying Breast Cancer
1,385 Patients Enrolled for Breast Cancer
Daiichi SankyoLead Sponsor
406 Previous Clinical Trials
448,647 Total Patients Enrolled
25 Trials studying Breast Cancer
17,072 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,368 Previous Clinical Trials
288,736,202 Total Patients Enrolled
176 Trials studying Breast Cancer
1,245,041 Patients Enrolled for Breast Cancer

Media Library

Trastuzumab deruxtecan (DS-8201a) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03734029 — Phase 3
Breast Cancer Research Study Groups: Trastuzumab deruxtecan, Physician's Choice
Breast Cancer Clinical Trial 2023: Trastuzumab deruxtecan (DS-8201a) Highlights & Side Effects. Trial Name: NCT03734029 — Phase 3
Trastuzumab deruxtecan (DS-8201a) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03734029 — Phase 3
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