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Monoclonal Antibodies

Trastuzumab Deruxtecan for Breast Cancer (DB-06 Trial)

Westbury, NY
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior chemotherapy for advanced or metastatic breast cancer
Has protocol-defined adequate organ and bone marrow function
Must not have
Uncontrolled or significant cardiovascular disease or infection
Patients with spinal cord compression or clinically active central nervous system metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to approximately 60 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new drug called trastuzumab deruxtecan for patients with advanced breast cancer that hasn't responded to other treatments. The drug works by specifically targeting and killing cancer cells. The study aims to see if this drug helps patients live longer or improves their quality of life compared to other treatments. Trastuzumab deruxtecan has shown significant clinical benefits in treating advanced breast cancer and other similar tumors.

Who is the study for?
This trial is for adults over 18 with advanced or metastatic breast cancer that has low HER2 expression and progressed after endocrine therapy. Participants must not have had prior chemotherapy for their advanced cancer, should have adequate organ function, and provide tumor samples to confirm HER2 status. Those with significant lung disease, uncontrolled heart conditions, active infections, or a history of certain lung problems are excluded.
What is being tested?
The study compares the effectiveness of Trastuzumab Deruxtecan (T-DXd) against standard chemotherapies like Capecitabine and Paclitaxel in patients with specific types of breast cancer. It aims to see which treatment is better at controlling the disease while monitoring safety and tolerability.
What are the potential side effects?
Trastuzumab Deruxtecan can cause side effects such as fatigue, nausea, hair loss, decreased blood cell counts increasing infection risk, potential heart damage or interstitial lung disease. Standard chemotherapies may also lead to similar side effects including nerve damage from Paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had chemotherapy for advanced breast cancer.
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My organs and bone marrow are functioning well.
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My breast cancer is advanced or has spread, and tests show specific HER2 levels.
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I am 18 years old or older.
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My condition worsened after treatment within a specific timeframe.
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I have enough tumor samples for HER2 testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart disease or infections.
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I have spinal cord compression or active brain metastases.
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I cannot receive standard chemotherapy treatments.
Select...
I have no serious lung illnesses besides my cancer.
Select...
I have or had lung inflammation that needed steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to approximately 60 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) - in HR+, HER2-low populaton
Secondary study objectives
Duration of response (DoR) - in HR+, HER-2 low populaton
Duration of response (DoR) - in the ITT population
Health-related quality of life - EORTC QLQ-BR45
+12 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

2Treatment groups
Experimental Treatment
Active Control
Group I: Trastuzumab deruxtecanExperimental Treatment1 Intervention
Trastuzumab deruxtecan (T-DXd; DS-8201a) arm
Group II: Standard of CareActive Control3 Interventions
Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2021
Completed Phase 2
~730

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
HER2-targeted therapies, such as Trastuzumab deruxtecan, are crucial for treating HER2-positive breast cancer. These treatments work by combining a HER2-targeting antibody with a cytotoxic drug, which is delivered directly to cancer cells, thereby inhibiting their growth and minimizing damage to normal cells. Other similar treatments include Trastuzumab, which blocks HER2 signaling, and Ado-trastuzumab emtansine, another antibody-drug conjugate. These therapies improve treatment efficacy and reduce side effects, offering significant benefits over traditional chemotherapy.

Find a Location

Closest Location:Research Site· Westbury, NY

Who is running the clinical trial?

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, TokyoUNKNOWN
2 Previous Clinical Trials
1,033 Total Patients Enrolled
AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,122,727 Total Patients Enrolled
177 Trials studying Breast Cancer
1,245,073 Patients Enrolled for Breast Cancer

Media Library

Trastuzumab Deruxtecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04494425 — Phase 3
Breast Cancer Research Study Groups: Trastuzumab deruxtecan, Standard of Care
Breast Cancer Clinical Trial 2023: Trastuzumab Deruxtecan Highlights & Side Effects. Trial Name: NCT04494425 — Phase 3
Trastuzumab Deruxtecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04494425 — Phase 3
~162 spots leftby Dec 2025