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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
Must not have
History of any prior (ipsi- or contralateral) breast cancer except lobular carcinoma in situ (LCIS)
Medical history of myocardial infarction (MI) within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer 28 days prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.
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.
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 below
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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.
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My cancer was not just a small tumor without spread to lymph nodes when diagnosed.
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My cancer is hormone receptor positive/negative according to a specific test.
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My surgery removed all visible cancer from my breast and underarm area.
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My surgery removed all visible cancer from my breast and lymph nodes.
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My breast cancer was too advanced to be operated on when first diagnosed.
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My cancer is confirmed HER2-positive by specific tests.
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I completed treatment with taxane and HER2-targeted therapy before surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is confirmed to be HER2-positive.
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My breast cancer is confirmed and not just at the earliest stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had breast cancer before, but not LCIS.
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I haven't had a heart attack or severe heart failure in the last 6 months.
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I have been treated with a certain amount of anthracycline drugs.
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I have severe lung problems like asthma, COPD, or had a recent pulmonary embolism.
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I have an autoimmune or inflammatory condition affecting my lungs.
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My breast cancer has spread to other parts of my body.
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My cancer is still visible after initial treatment and surgery.
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I have previously been treated with specific HER2-targeted therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 2 trial • 253 Patients • NCT03248492
76%
Nausea
50%
Alopecia
46%
Vomiting
42%
Fatigue
32%
Neutrophil count decreased
32%
Anemia
32%
Constipation
30%
Diarrhea
30%
Decreased appetite
24%
White blood cell count decreased
20%
Stomatitis
18%
Aspartate aminotransferase increased
18%
Cough
18%
Asthenia
16%
Gastroesophageal reflux disease
16%
Platelet count decreased
14%
Headache
14%
Neutropenia
14%
Alanine aminotransferase increased
12%
Upper respiratory tract infection
12%
Epistaxis
12%
Dizziness
10%
Electrocardiogram QT prolonged
10%
Nasopharyngitis
10%
Dyspnea
10%
Weight decreased
10%
Abdominal pain
10%
Insomnia
8%
Dysgeusia
8%
Interstitial lung disease
8%
Blood lactate dehydrogenase increased
8%
Urinary tract infection
8%
Pneumonitis
8%
Blood bilirubin increased
8%
Dry eye
8%
Myalgia
6%
Cellulitis
6%
Peripheral sensory neuropathy
6%
Hypokalemia
6%
Dyspepsia
6%
Abdominal pain upper
6%
Hemorrhoids
6%
Abdominal distension
6%
Toothache
6%
Arthralgia
6%
Lymphocyte count decreased
6%
Infusion-related reaction
6%
Herpes zoster
6%
Troponin I increased
6%
Anxiety
6%
Skin hyperpigmentation
6%
Malaise
4%
Cystitis
4%
Thrombocytopenia
4%
Hypomagnesemia
4%
Dry skin
4%
Odema peripheral
4%
Lymphopenia
4%
Pleural effusion
4%
Neuropathy peripheral
4%
Pain in extremity
4%
Pyrexia
4%
Keratitis
2%
Blood alkaline phosphatase increased
2%
Visual impairment
2%
Back pain
2%
Diverticulitis
2%
Hypersensitivity
2%
Upper gastrointestinal hemorrhage
2%
Hypoalbuminemia
2%
Nail disorder
2%
Gamma-glutamyltransferase increased
2%
Ejection fraction decreased
2%
Abdominal discomfort
2%
Osteomyelitis
2%
Shock hemorrhagic
2%
Pharyngitis
2%
Rash
2%
Muscle spasms
2%
Mucosal inflammation
2%
Presyncope
2%
Pyelonephritis
2%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: DS-8201a Low Dose
Part 1: DS-8201a Medium Dose
Part 1: DS-8201a High Dose
Part 2a: DS-8201a Low Dose
Part 2b (Exploratory): DS-8201a Low Dose

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
2017
Completed Phase 2
~680

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
406 Previous Clinical Trials
447,604 Total Patients Enrolled
26 Trials studying Breast Cancer
17,629 Patients Enrolled for Breast Cancer
German Breast GroupOTHER
53 Previous Clinical Trials
46,843 Total Patients Enrolled
28 Trials studying Breast Cancer
36,572 Patients Enrolled for Breast Cancer
Spanish Breast Cancer Research Group (SOLTI)UNKNOWN

Media Library

Trastuzumab Deruxtecan (T-DXd) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04622319 — Phase 3
Breast Cancer Research Study Groups: Trastuzumab deruxtecan (T-DXd), Trastuzumab ematansine (T-DM1)
Breast Cancer Clinical Trial 2023: Trastuzumab Deruxtecan (T-DXd) Highlights & Side Effects. Trial Name: NCT04622319 — Phase 3
Trastuzumab Deruxtecan (T-DXd) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04622319 — Phase 3
~373 spots leftby Dec 2025
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