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Monoclonal Antibodies
Trastuzumab Deruxtecan for Breast Cancer (DB-06 Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to approximately 60 months
Awards & highlights
DB-06 Trial Summary
This trial will compare the effectiveness of a new drug, trastuzumab deruxtecan, with standard chemotherapy in treating HER2-low, hormone receptor-positive breast cancer that has progressed despite endocrine therapy.
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.Check my eligibility
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.See study design
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.
DB-06 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had chemotherapy for advanced breast cancer.
Select...
My organs and bone marrow are functioning well.
Select...
My breast cancer is advanced or has spread, and tests show specific HER2 levels.
Select...
I am 18 years old or older.
Select...
My condition worsened after treatment within a specific timeframe.
Select...
I have enough tumor samples for HER2 testing.
DB-06 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed up to approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to approximately 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS) - in HR+, HER2-low populaton
Secondary outcome measures
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 moreSide effects data
From 2024 Phase 2 trial • 79 Patients • NCT0401407565%
Nausea
44%
Vomiting
42%
Fatigue
38%
Anaemia
37%
Diarrhoea
35%
Weight Decreased
33%
Decreased Appetite
29%
Constipation
24%
Alopecia
18%
Platelet Count Decreased
16%
Neutrophil Count Decreased
16%
Aspartate Aminotransferase Increased
16%
Hypokalaemia
15%
Asthenia
14%
Abdominal Pain
11%
Pyrexia
11%
Cough
11%
White Blood Cell Count Decreased
11%
Blood Alkaline Phosphatase Increased
10%
Neutropenia
10%
Hypoalbuminaemia
10%
Epistaxis
10%
Gastrooesophageal Reflux Disease
10%
Alanine Aminotransferase Increased
9%
Back Pain
9%
Dyspnoea
9%
Headache
8%
Hyponatraemia
8%
Hypotension
8%
Dizziness
6%
Urinary Retention
6%
Ascites
6%
Pneumonitis
6%
Abdominal Pain Upper
6%
Dysphagia
6%
Covid-19
6%
Insomnia
6%
Thrombocytopenia
6%
Weight Increased
6%
Blood Bilirubin Increased
5%
Acute Kidney Injury
5%
Interstitial Lung Disease
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%
Colitis
1%
Wound Infection
1%
Covid-19 Pneumonia
1%
Hyperpyrexia
1%
Staphylococcal Infection
1%
Haematemesis
1%
Bacterial Sepsis
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
DB-06 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
2022
Completed Phase 2
~400
Find a Location
Who is running the clinical trial?
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, TokyoUNKNOWN
1 Previous Clinical Trials
413 Total Patients Enrolled
AstraZenecaLead Sponsor
4,261 Previous Clinical Trials
288,593,305 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart disease or infections.I haven't had chemotherapy for advanced breast cancer.My organs and bone marrow are functioning well.I have spinal cord compression or active brain metastases.My breast cancer is advanced or has spread, and tests show specific HER2 levels.I cannot receive standard chemotherapy treatments.I have no serious lung illnesses besides my cancer.I am 18 years old or older.I have or had lung inflammation that needed steroids.My condition worsened after treatment within a specific timeframe.I have enough tumor samples for HER2 testing.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab deruxtecan
- Group 2: Standard of Care
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a person is under 70 years old, can they join this experiment?
"This particular clinical trial only enrolls patients that are between 18 to 105 years old. In general, there are 91 clinical trials for minors and 3,464 for senior citizens."
Answered by AI
What precedent exists for Trastuzumab deruxtecan's efficacy?
"Trastuzumab deruxtecan was first studied in 1997 and, as of now, 1670 completed studies exist. There are 1203 ongoing studies currently looking for participants, a majority of which are based in Bethesda, Maryland."
Answered by AI
What are some of the benefits that Trastuzumab deruxtecan provides patients?
"Trastuzumab deruxtecan is most commonly used to treat patients with locally advanced non-small cell lung cancer, however it can also be used for metastatic bladder cancer, acquired immunodeficiency syndrome, and advanced thymoma."
Answered by AI
Could you outline the eligibility requirements for this research project?
"This study is for patients with malignant neoplasms who are between 18 and 105 years old. Up to 850 people can join the clinical trial."
Answered by AI
Has Trastuzumab deruxtecan been cleared by the FDA?
"Trastuzumab deruxtecan is considered safe according to our team's assessment, which is reflected by its Phase 3 clinical trial status."
Answered by AI
Are there a great deal of test sites for this experiment located in Canada?
"There are 37 sites enrolling patients for this clinical trial, with locations in cities such as Bethesda, Camden, and Austin. You can select the location closest to you to limit travel if you decide to participate."
Answered by AI
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