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Monoclonal Antibodies

Trastuzumab Deruxtecan for Breast Cancer

Phase 3
Recruiting
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above.
Is hormone receptor-negative or hormone receptor-positive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 24 months
Awards & highlights

Summary

This trial is testing a new treatment called trastuzumab deruxtecan (T-DXd) in people with a specific type of breast cancer. The goal is to see if this treatment

Who is the study for?
This trial is for adults with unresectable/metastatic breast cancer that's either hormone receptor-negative or -positive but HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 IHC 0. Participants must not have been previously treated with anti-HER2 therapy in the metastatic setting and should have had one to two prior lines of therapy for their metastatic disease.
What is being tested?
The study tests Trastuzumab Deruxtecan (T-DXd) on patients with specific types of breast cancer. It aims to assess how safe and effective T-DXd is in treating those whose tumors are low in a protein called HER2, which can affect cancer growth.
What are the potential side effects?
While the side effects of T-DXd will be monitored during the trial, they may include nausea, fatigue, hair loss, lowered blood cell counts leading to increased infection risk, potential heart issues, and possible lung problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as HER2-low or HER2-negative.
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My cancer may or may not respond to hormones.
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My breast cancer cannot be removed by surgery and/or has spread.
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My cancer was never previously tested positive for HER2.
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I have received 1 or 2 treatments for my cancer after it spread.
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I have never had anti-HER2 therapy for cancer that has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT)
Secondary study objectives
Mean Change From Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Index Score
Mean Change From Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)
Mean Change from Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L)
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: HR-positive, HER2 IHC 0Experimental Treatment1 Intervention
Participants with HR-positive HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
Group II: Cohort 3: HR-positive, HER2-lowExperimental Treatment1 Intervention
Participants with HR-positive HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd. Participants must also have recurrent disease \<2 years from the initiation of adjuvant ET or have disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor or have disease progression within the first 12 months of CDK4/6 in the first line metastatic setting.
Group III: Cohort 2: HR-negative, HER2 IHC 0Experimental Treatment1 Intervention
Participants with HR-negative HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
Group IV: Cohort 1: HR-negative, HER2-lowExperimental Treatment1 Intervention
Participants with HR-negative HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab Deruxtecan
2021
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
401 Previous Clinical Trials
446,810 Total Patients Enrolled
25 Trials studying Breast Cancer
17,414 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,350 Total Patients Enrolled
27 Trials studying Breast Cancer
19,389 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,559 Total Patients Enrolled
175 Trials studying Breast Cancer
1,245,328 Patients Enrolled for Breast Cancer
~167 spots leftby Oct 2027
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