Your session is about to expire
← Back to Search
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 46 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 46 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 46 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) 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 outcome measures
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 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
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
2022
Completed Phase 2
~400
Find a Location
Who is running the clinical trial?
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
410,757 Total Patients Enrolled
25 Trials studying Breast Cancer
17,019 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
414,689 Total Patients Enrolled
27 Trials studying Breast Cancer
18,994 Patients Enrolled for Breast Cancer
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
48,478 Total Patients Enrolled
3 Trials studying Breast Cancer
1,334 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was in a Daiichi Sankyo antibody drug study but my disease didn't worsen within 12 months after.I have serious heart problems that are not under control.I agree to use effective birth control or avoid sex during the study and for months after.My blood, kidney, and liver functions are all within normal ranges.I have been treated with capecitabine before.I am legally considered an adult in my country.I have or had lung inflammation that needed steroids.My cancer has spread to my brain.My breast cancer cannot be removed by surgery or has spread.I was treated with ado-trastuzumab emtansine (T-DM1) before.My cancer has grown or spread on scans after my last treatment or within 6 months of completing treatment.My cancer is confirmed HER2-positive by specific guidelines.My most recent tumor tissue is HER2 positive, or I agree to a new biopsy if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab deruxtecan (DS-8201a)
- Group 2: Lapatinib+capecitabine
- Group 3: Trastuzumab+capecitabine
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.
How many participants are being welcomed into this clinical trial?
"This study is no longer looking for participants. The original posting date was 8/1/2018, with the last edit being on 8/11/2022. For patients searching for other trials, 2677 studies for breast cancer and 571 for Trastuzumab deruxtecan are still recruiting."
Answered by AI
What is the usual application of Trastuzumab deruxtecan?
"Trastuzumab deruxtecan is most often used to treat refractory fallopian tube carcinoma. However, it can also be prescribed to patients with high risk of recurrence, metastatic colorectal carcinoma, or breast cancer."
Answered by AI
Is Trastuzumab deruxtecan a new or experimental drug?
"Presently, 571 different Trastuzumab deruxtecan trials are ongoing with 181 in Phase 3. While some of these clinical trials are based in Seattle, there are a total of 27868 locations for these studies."
Answered by AI
Could you please explain the possible dangers of Trastuzumab deruxtecan?
"The safety of Trastuzumab deruxtecan was given a score of 3 out of 3 by our team at Power. A Phase 3 trial indicates that, not only is there some data supporting efficacy, but multiple rounds of data also support safety."
Answered by AI
At how many different hospitals or research centers can patients enroll in this trial?
"There are 41 running for this study such as Memorial Sloan-Kettering Cancer Center (MSKCC) - New york in New York, Community Hospital in Munster, and Abramson Cancer Center in Philadelphia, as well as other locations."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger