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Monoclonal Antibodies
T-DXd vs. T-DM1 for Residual 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
Histologically confirmed invasive breast carcinoma
Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting specific high-risk criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 81 months postdose
Awards & highlights
Study Summary
This trial will compare the effectiveness of two drugs for treating breast cancer that has come back after initial treatment.
Who is the study for?
This trial is for adults over 18 with HER2-positive breast cancer who didn't have a complete response after neoadjuvant therapy. They should have had surgery to remove the disease, not be stage IV, and must not have received certain drugs like T-DXd or T-DM1 before. Participants need good heart function and no history of severe lung or heart conditions.Check my eligibility
What is being tested?
The study compares Trastuzumab Deruxtecan (T-DXd) with Trastuzumab Emtansine (T-DM1) in patients at high risk of recurrence after initial treatment for invasive breast cancer. It aims to find out which drug is safer and more effective as a follow-up therapy.See study design
What are the potential side effects?
Possible side effects include allergic reactions, fatigue, nausea, blood disorders, liver issues, and potential heart problems. There's also a concern about lung complications such as interstitial lung disease or pneumonitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer has been confirmed by a biopsy.
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I still have cancer in my breast or lymph nodes after initial treatment.
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I've completed over 16 weeks of pre-surgery treatment including trastuzumab and taxane.
Select...
My cancer was not just a small tumor without spread to lymph nodes when diagnosed.
Select...
My cancer is hormone receptor positive/negative according to a specific test.
Select...
My surgery removed all visible cancer from my breast and underarm area.
Select...
My surgery removed all visible cancer from my breast and lymph nodes.
Select...
My breast cancer was too advanced to be operated on when first diagnosed.
Select...
My cancer is confirmed HER2-positive by specific tests.
Select...
I completed treatment with taxane and HER2-targeted therapy before surgery.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer is confirmed to be HER2-positive.
Select...
My breast cancer is confirmed and not just at the earliest stage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 81 months postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 81 months postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Brain Metastases-free Interval (BMFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
Therapeutic procedure
Distant Recurrence-free Interval (DRFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
+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
2Treatment groups
Experimental Treatment
Active Control
Group I: Trastuzumab deruxtecan (T-DXd)Experimental Treatment1 Intervention
Participants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.
Group II: Trastuzumab ematansine (T-DM1)Active Control1 Intervention
Participants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DS-8201a
2018
Completed Phase 2
~430
Find a Location
Who is running the clinical trial?
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
409,765 Total Patients Enrolled
26 Trials studying Breast Cancer
17,627 Patients Enrolled for Breast Cancer
German Breast GroupOTHER
52 Previous Clinical Trials
46,723 Total Patients Enrolled
28 Trials studying Breast Cancer
36,572 Patients Enrolled for Breast Cancer
Spanish Breast Cancer Research Group (SOLTI)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping function (LVEF) is at least 50% within the last 28 days before joining the study.My breast cancer has been confirmed by a biopsy.I still have cancer in my breast or lymph nodes after initial treatment.I've completed over 16 weeks of pre-surgery treatment including trastuzumab and taxane.My cancer was not just a small tumor without spread to lymph nodes when diagnosed.My organs are functioning well as of the last two weeks.My cancer is hormone receptor positive/negative according to a specific test.I have had breast cancer before, but not LCIS.I have had lung inflammation that needed steroids, or it shows on a chest CT scan.My surgery removed all visible cancer from my breast and underarm area.I am 18 years old or older.My surgery removed all visible cancer from my breast and lymph nodes.My breast cancer was too advanced to be operated on when first diagnosed.My cancer is confirmed HER2-positive by specific tests.I completed treatment with taxane and HER2-targeted therapy before surgery.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had a heart attack or severe heart failure in the last 6 months.I have been treated with a certain amount of anthracycline drugs.My breast cancer is confirmed to be HER2-positive.I have severe lung problems like asthma, COPD, or had a recent pulmonary embolism.I have an autoimmune or inflammatory condition affecting my lungs.I haven't had cancer in the last 5 years, except for certain low-risk types.My breast cancer has spread to other parts of my body.My cancer is still visible after initial treatment and surgery.My last surgery was no more than 12 weeks ago.I have previously been treated with specific HER2-targeted therapies.My breast cancer is confirmed and not just at the earliest stage.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab deruxtecan (T-DXd)
- Group 2: Trastuzumab ematansine (T-DM1)
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.
What is the main indication for DS-8201a?
"DS-8201a is a common treatment for breast cancer, but can also shrink tumours in patients with high risk of recurrence, first line treatment, and surgery."
Answered by AI
When can we expect DS-8201a to be given the green light by the FDA?
"DS-8201a received a safety score of 3 because there is existing clinical data that supports its efficacy and multiple rounds of data affirming its safety."
Answered by AI
What else is known about DS-8201a from clinical research?
"DS-8201a is currently being studied in 254 active clinical trials, 61 of which are Phase 3 studies. Although many of the DS-8201a studies are based in Rochester, Minnesota, there are a total of 18395 locations running trials for this treatment globally."
Answered by AI
How many people have been recruited to participate in this research?
"This clinical trial requires 1600 participants that meet the necessary inclusion criteria. The sponsor, Daiichi Sankyo, Inc., will be administering the trial from multiple locations including SCRI FCS South- Lakewood Ranch in Lakewood Ranch, Florida and Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center in Elmhurst, Illinois."
Answered by AI
Are there vacancies in this clinical trial for new patients?
"The clinical trial is currently looking for enrollees, according to the postings on clinicaltrials.gov. This specific study was posted on December 4th, 2020 and was last edited November 7th, 2022."
Answered by AI
Are there many different places in the US where this clinical trial is being conducted?
"One hundred different medical centres are currently enrolling patients in this clinical trial. While the locations span across Lakewood Ranch, Elmhurst and Baton Rouge, other less centralised locations are also participating. If you choose to take part in this study, try to select a location close to reduce travel time commitments."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Arizona
Other
New York
What site did they apply to?
Baptist Health Louisville
What portion of applicants met pre-screening criteria?
Met criteria
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