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Monoclonal Antibodies

Trastuzumab deruxtecan for Breast Cancer

Phase 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 cycles (within 2 months; each cycle is 21 days)
Awards & highlights

Study Summary

This trial is studying a new combination drug treatment for HER2-positive breast cancer that has spread or returned after previous treatment. The drug combination includes trastuzumab deruxtecan, a cancer drug, and nivolumab, an immunotherapy drug. The trial will be done in two parts. Part 1 will find the best dose to use. Part 2 will study how well the combination works, how safe it is, and how well it is tolerated.

Eligible Conditions
  • Breast Cancer
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 cycles (within 2 months; each cycle is 21 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 cycles (within 2 months; each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of participants with dose-limiting toxicity at each dose level
Heart rate
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Number of participants with treatment emergent adverse events (TEAEs) during the trial
+4 more

Side effects data

From 2024 Phase 2 trial • 79 Patients • NCT04014075
65%
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

5Treatment groups
Experimental Treatment
Group I: Dose Expansion - Cohort 4Experimental Treatment2 Interventions
Cohort 4 (n=15): Participants with pathologically documented advanced/metastatic urothelial carcinoma that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression. Participants will receive the RDE of trastuzumab deruxtecan and the flat dose of nivolumab.
Group II: Dose Expansion - Cohort 3Experimental Treatment2 Interventions
Cohort 3 (n=30): Participants with pathologically documented advanced/metastatic urothelial carcinoma that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression. Participants will receive the RDE of trastuzumab deruxtecan and the flat dose of nivolumab.
Group III: Dose Expansion - Cohort 2Experimental Treatment2 Interventions
Cohort 2 (n=15): Participants with pathologically documented advanced/metastatic breast cancer that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-), who have exhausted treatments that can confer any clinically meaningful benefit (eg, other therapies such as hormonal therapy for patients who are hormone receptor positive). Participants will receive the RDE of trastuzumab deruxtecan and the flat dose of nivolumab.
Group IV: Dose Expansion - Cohort 1Experimental Treatment2 Interventions
Cohort 1 (n=30): Participants with pathologically documented advanced/metastatic breast cancer that has centrally-determined positive HER2 expression (IHC 3+ or IHC 2+/ISH+) [as defined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines]. These participants have received prior ado-trastuzumab emtansine (T-DM1). Participants will receive the RDE of trastuzumab deruxtecan and the flat dose of nivolumab.
Group V: Dose EscalationExperimental Treatment2 Interventions
Part 1 will enroll participants meeting the eligibility criteria set up for any of the 4 cohorts of Part 2 specified below using a 3 + 3 + 3 design. Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab will be administered on Day 1 of each 21-day cycle. The recommended dose for expansion (RDE) will be calculated using data collected from this population in the first two cycles. These participants may continue to receive study treatment in subsequent cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
FDA approved
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
411,266 Total Patients Enrolled
25 Trials studying Breast Cancer
17,528 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
415,198 Total Patients Enrolled
27 Trials studying Breast Cancer
19,503 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,415 Total Patients Enrolled
50 Trials studying Breast Cancer
8,166 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
2018. "Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03523572.
~14 spots leftby Apr 2025
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