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Antibody-drug conjugate

Trastuzumab Deruxtecan for Advanced 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 pathologically documented breast cancer that is unresectable or metastatic
Was previously treated with ado-trastuzumab emtansine (T-DM1)
Must not have
Has uncontrolled or significant cardiovascular disease
Has had prior treatment with capecitabine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 46 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare DS 8201a, a new HER2-targeted treatment, to standard treatment for HER2 breast cancer that has been treated before and cannot be removed by surgery.

Who is the study for?
This trial is for adults with HER2-positive breast cancer that's either inoperable or has spread, and who have previously been treated with T-DM1. They must not have participated in certain other drug studies, have no serious heart disease or lung conditions, and agree to use effective contraception.
What is being tested?
The study compares a new medication called DS-8201a (Trastuzumab deruxtecan) against standard treatments like Capecitabine, Trastuzumab, and Lapatinib. It aims to see if DS-8201a is more effective for those who've had prior treatment.
What are the potential side effects?
Potential side effects include typical chemotherapy reactions such as nausea, fatigue, hair loss; targeted therapy issues like allergic reactions; plus specific concerns from DS-8201a which may involve blood count changes and potential lung problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer cannot be removed by surgery or has spread.
Select...
I was treated with ado-trastuzumab emtansine (T-DM1) before.
Select...
My cancer is confirmed HER2-positive by specific guidelines.
Select...
My most recent tumor tissue is HER2 positive, or I agree to a new biopsy if needed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have serious heart problems that are not under control.
Select...
I have been treated with capecitabine before.
Select...
I have or had lung inflammation that needed steroids.
Select...
My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 46 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 46 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
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Secondary study objectives
Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
+1 more

Side effects data

From 2024 Phase 2 trial • 79 Patients • NCT04014075
65%
Nausea
44%
Vomiting
42%
Fatigue
38%
Anaemia
37%
Diarrhoea
35%
Weight Decreased
33%
Decreased Appetite
29%
Constipation
24%
Alopecia
18%
Platelet Count Decreased
16%
Hypokalaemia
16%
Neutrophil Count Decreased
16%
Aspartate Aminotransferase Increased
15%
Asthenia
14%
Abdominal Pain
11%
Cough
11%
Pyrexia
11%
White Blood Cell Count Decreased
11%
Blood Alkaline Phosphatase Increased
10%
Epistaxis
10%
Hypoalbuminaemia
10%
Neutropenia
10%
Gastrooesophageal Reflux Disease
10%
Alanine Aminotransferase Increased
9%
Dyspnoea
9%
Back Pain
9%
Headache
8%
Hypotension
8%
Hyponatraemia
8%
Dizziness
6%
Pneumonitis
6%
Ascites
6%
Urinary Retention
6%
Abdominal Pain Upper
6%
Dysphagia
6%
Covid-19
6%
Insomnia
6%
Thrombocytopenia
6%
Weight Increased
6%
Blood Bilirubin Increased
5%
Interstitial Lung Disease
5%
Acute Kidney Injury
5%
Device Related Infection
5%
Hypophosphataemia
5%
Depression
5%
Flatulence
5%
Mucosal Inflammation
5%
Blood Creatinine Increased
5%
Urinary Tract Infection
5%
Oedema Peripheral
3%
Pneumonia
3%
Disease Progression
3%
Malignant Neoplasm Progression
1%
Hyperpyrexia
1%
Colitis
1%
Haematemesis
1%
Wound Infection
1%
Bacterial Sepsis
1%
Staphylococcal Infection
1%
Covid-19 Pneumonia
1%
Intestinal Obstruction
1%
Animal Bite
1%
Enteritis
1%
Basal Ganglia Infarction
1%
Cerebrovascular Accident
1%
Generalised Tonic-Clonic Seizure
1%
Pulmonary Embolism
1%
Lymphangiosis Carcinomatosa
1%
Tumour Haemorrhage
1%
Bile Duct Stenosis
1%
Hepatotoxicity
1%
Hydronephrosis
1%
Urinary Tract Obstruction
1%
Exposure To Communicable Disease
1%
Device Occlusion
1%
Catheter Site Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab Deruxtecan

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Trastuzumab deruxtecan (DS-8201a)Experimental Treatment1 Intervention
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
Group II: Lapatinib+capecitabineActive Control2 Interventions
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine
Group III: Trastuzumab+capecitabineActive Control2 Interventions
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
412 Previous Clinical Trials
450,527 Total Patients Enrolled
25 Trials studying Breast Cancer
17,021 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,066 Total Patients Enrolled
25 Trials studying Breast Cancer
17,021 Patients Enrolled for Breast Cancer
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
48,600 Total Patients Enrolled
3 Trials studying Breast Cancer
1,334 Patients Enrolled for Breast Cancer

Media Library

Trastuzumab deruxtecan (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03523585 — Phase 3
Breast Cancer Research Study Groups: Trastuzumab deruxtecan (DS-8201a), Lapatinib+capecitabine, Trastuzumab+capecitabine
Breast Cancer Clinical Trial 2023: Trastuzumab deruxtecan Highlights & Side Effects. Trial Name: NCT03523585 — Phase 3
Trastuzumab deruxtecan (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03523585 — Phase 3
~84 spots leftby Nov 2025
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