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Antibody-Drug Conjugate
DS-8201a for Breast Cancer
Phase 2
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 HER2 positive expression confirmed per protocol
Has pathologically documented breast cancer that is unresectable or metastatic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Awards & highlights
Study Summary
This trial is testing a new experimental product, DS-8201a, to see if it can help patients with HER-2 positive breast cancer who have not responded to current treatment, or have become resistant to it. DS-8201a is a combination of an antibody and a drug. If it is effective, it could help to slow down tumor growth and improve outcomes for patients.
Who is the study for?
This trial is for adults with HER2 positive, unresectable or metastatic breast cancer who have measurable tumors and good heart, kidney, and liver function. Participants must agree to use contraception and provide a tumor sample. It's not for those with certain serious health conditions like heart failure, significant lung disease, or abnormal heart rhythm.Check my eligibility
What is being tested?
DS-8201a is being tested in this study; it's an experimental drug that combines an antibody with medication aimed at slowing tumor growth in patients whose breast cancer hasn't responded to current treatments like Trastuzumab Emtansine (T-DM1).See study design
What are the potential side effects?
While the specific side effects of DS-8201a are not listed here, similar drugs often cause reactions where the drug enters the body, fatigue, nausea or vomiting. There may also be risks related to organ inflammation due to immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed to be HER2 positive.
Select...
My breast cancer cannot be removed by surgery or has spread.
Select...
My heart, kidneys, and liver are functioning well.
Select...
I have a sufficient sample of my tumor available.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Secondary outcome measures
Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
+4 moreSide effects data
From 2020 Phase 2 trial • 233 Patients • NCT0332969079%
Nausea
75%
Decreased appetite
50%
Neutrophil count decreased
46%
Anaemia
38%
Malaise
33%
Diarrhoea
29%
Vomiting
29%
Platelet count decreased
29%
Weight decreased
29%
White blood cell count decreased
25%
Fatigue
25%
Pyrexia
21%
Constipation
21%
Hypoalbuminaemia
17%
Hypokalaemia
17%
Blood alkaline phosphatase increased
13%
Ascites
13%
Lymphocyte count decreased
13%
Embolism
8%
Dyspepsia
8%
Nasopharyngitis
8%
Tumour pain
8%
Hypoglycaemia
8%
Abdominal distension
8%
Oedema peripheral
8%
Asthenia
8%
Gastric haemorrhage
8%
Stomatitis
8%
Cancer pain
8%
Hyponatraemia
8%
Arthralgia
8%
Pleural effusion
4%
Lung infection
4%
Hypocalcaemia
4%
Hepatic function abnormal
4%
Alopecia
4%
Hydronephrosis
4%
Aspartate aminotransferase increased
4%
Blood creatinine increased
4%
Interstitial lung disease
4%
Pneumonia
4%
Blood bilirubin increased
4%
Hiccups
4%
Anal haemorrhage
4%
Pain in extremity
4%
Jaundice cholestatic
4%
Insomnia
4%
Dysgeusia
4%
Abdominal pain
4%
Dry skin
4%
Back pain
4%
Hyperkalaemia
4%
Influenza
4%
Sepsis
4%
Keratitis
4%
Corneal erosion
4%
Cholangitis
4%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Physician's Choice Paclitaxel
DS-8201a
Physician's Choice Overall
Physician's Choice Irinotecan
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Trial Design
4Treatment groups
Experimental Treatment
Group I: Exploratory ArmExperimental Treatment1 Intervention
In Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm
Group II: DS-8201a Medium DoseExperimental Treatment1 Intervention
T-DM1 resistant/refractory (R/R) patients in the medium dose treatment group
Group III: DS-8201a Low DoseExperimental Treatment1 Intervention
T-DM1 resistant/refractory (R/R) patients in the low dose treatment group
Group IV: DS-8201a High DoseExperimental Treatment1 Intervention
T-DM1 resistant/refractory (R/R) patients in the high dose treatment group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
FDA approved
Find a Location
Who is running the clinical trial?
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
411,112 Total Patients Enrolled
25 Trials studying Breast Cancer
17,374 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
415,044 Total Patients Enrolled
27 Trials studying Breast Cancer
19,349 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,533 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,086 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed to be HER2 positive.My breast cancer cannot be removed by surgery or has spread.I have a history of serious heart conditions, including heart attack or heart failure.I am legally considered an adult in my country.My heart, kidneys, and liver are functioning well.Your heart's electrical activity is too slow, taking longer than usual to reset.You have at least one detectable tumor that can be measured using specific guidelines.I have a sufficient sample of my tumor available.You may have certain other specified diseases based on screening imaging.I have a history of serious lung disease.
Research Study Groups:
This trial has the following groups:- Group 1: DS-8201a Low Dose
- Group 2: DS-8201a Medium Dose
- Group 3: DS-8201a High Dose
- Group 4: Exploratory Arm
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What potential risks does DS-8201a pose to individuals?
"The safety of DS-8201a received a rating of 2 on our scale, as this is only Phase 2 and does not have any evidence to support its efficacy yet."
Answered by AI
Is this the inaugural clinical trial of its type?
"At present, Daiichi Sankyo Inc. is running 36 clinical trials for DS-8201a across the globe in 44 different nations and 483 cities. The inaugural trial was launched in 2015 with 292 participants, achieving Phase 1 drug approval status before concluding. Since then, 5 further studies have been completed successfully."
Answered by AI
Are there vacancies available for prospective participants of this research trial?
"Unfortunately, no more participants are being recruited for this trial. It was published on August 25th 2017 and later updated on October 17th 2022. If you are looking to join another study there are currently 2,596 trials recruiting patients with breast cancer and 36 clinical studies seeking people interested in DS-8201a."
Answered by AI
How many participants are being recruited for the research project?
"This clinical trial has concluded its recruitment process. Initially posted on August 25th 2017, the study was last edited on October 17th 2022. Currently, there are 2,596 medical trials recruiting patients with breast cancer and 36 studies accepting enrollments for DS-8201a experiments."
Answered by AI
Have any prior investigations explored the implications of DS-8201a?
"Currently, 10 trials of DS-8201a are at the Phase 3 stage. Although many locations to participate in these studies are located near Phoenix, Arizona, there is a total of 3277 sites offering this clinical trial."
Answered by AI
How many venues are hosting this experiment?
"37 medical sites are currently recruiting patients for this trial, such as Providence Regional Medical Center - Everett in Everett, The University of Texas Health Science Center at Tyler in Fairfax and Virginia Cancer Specialists, PC in Los Angeles."
Answered by AI
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