Study Summary
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: Randomization to date of death, due to any cause, up to 87 months from first subject in
Day 21
Pharmacokinetics of Dato-DXd
Month 6
Immunogenicity of Dato-DXd
Month 57
Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT
Month 24
Fatigue in participants treated with Dato-DXd with or without durvalumab vs ICT
Month 87
OS for Dato-DXd vs ICT
Overall Survival (OS) for Dato-DXd + durvalumab vs ICT
Month 57
DDFS for Dato-DXd + durvalumab vs Dato-DXd
Month 36
Time to Deterioration (TTD) in GHS/QoL in participants treated with Dato-DXd with or without durvalumab compared with ICT
Time to Deterioration (TTD) in physical functioning in participants treated with Dato-DXd with or without durvalumab compared with ICT
Month 57
DDFS for Dato-DXd vs ICT
Distant disease-free survival (DDFS) for Dato-DXd + durvalumab vs ICT
Month 57
iDFS for Dato-DXd + durvalumab vs Dato-DXd
iDFS for Dato-DXd vs ICT
Day 90
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
Investigators Choice Therapy
1 of 3
Dato-DXd in combination with Durvalumab
1 of 3
Dato-DXd
1 of 3
Active Control
Experimental Treatment
1075 Total Participants · 3 Treatment Groups
Primary Treatment: Dato-DXd in combination with Durvalumab · No Placebo Group · Phase 3
Dato-DXd in combination with DurvalumabExperimental Group · 2 Interventions: Durvalumab, Dato-DXd · Intervention Types: Drug, Drug
Dato-DXd
Drug
Experimental Group · 1 Intervention: Dato-DXd · Intervention Types: DrugInvestigators Choice TherapyActiveComparator Group · 2 Interventions: Capecitabine, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3220
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: randomization to date of death, due to any cause, up to 87 months from first subject in
Who is running the clinical trial?
SWOG Clinical Trials PartnershipsUNKNOWN
AstraZenecaLead Sponsor
3,988 Previous Clinical Trials
91,856,387 Total Patients Enrolled
159 Trials studying Breast Cancer
1,235,867 Patients Enrolled for Breast Cancer
SWOG Clinical Trials PartnershipUNKNOWN
Daiichi Sankyo, Inc.Industry Sponsor
359 Previous Clinical Trials
340,700 Total Patients Enrolled
19 Trials studying Breast Cancer
14,065 Patients Enrolled for Breast Cancer
Aditya Bardia, MD, MPHStudy ChairMassachusetts General Hospital
2 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Breast Cancer
75 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18 - 130 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be at least 18 years old to be screened for this condition.
You have histologically confirmed invasive TNBC.
You have no deterioration in your ECOG performance status over the previous 2 weeks.
You must provide a tissue-based sample of the tumour at surgery for tissue-based analysis.
Radiotherapy (if indicated) delivered before the start of study intervention.
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Conditions
Cancer Related
Treatments