Dato-DXd for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Taoyuan, Taiwan
Breast Cancer+2 More
Dato-DXd - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Breast Cancer

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: From randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 26 months)

Month 26
Pharmacokinetics of Dato-DXd
Month 26
Immunogenicity of Dato-DXd
Safety of Dato-DXd
Month 26
Progression Free Survival 2 (PFS2)
Month 26
Progression-Free Survival (PFS) by Investigator assessment
Month 42
Overall Survival (OS)
Month 26
Time to First Subsequent Therapy (TFST)
Month 26
Time to Second Subsequent Therapy (TSST)
Month 26
Objective Response Rate (ORR)
Month 26
Progression Free Survival (PFS)
Month 26
Duration of Response (DoR)
Week 18
Time to deterioration (TTD) in GHS/QoL in participants treated with Dato DXd compared with ICC
Time to deterioration (TTD) in breast and arm symptoms in participants treated with Dato DXd compared to ICC
Time to deterioration (TTD) in pain in participants treated with Dato DXd compared with ICC
Time to deterioration (TTD) in physical functioning in participants treated with Dato DXd compared with ICC

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Breast Cancer

Trial Design

2 Treatment Groups

Investigator's Choice of Chemotherapy (ICC)
1 of 2
Dato-DXd
1 of 2
Active Control
Experimental Treatment

600 Total Participants · 2 Treatment Groups

Primary Treatment: Dato-DXd · No Placebo Group · Phase 3

Dato-DXd
Drug
Experimental Group · 1 Intervention: Dato-DXd · Intervention Types: Drug
Investigator's Choice of Chemotherapy (ICC)ActiveComparator Group · 5 Interventions: Paclitaxel, Nab-paclitaxel, Carboplatin, Capecitabine, Eribulin mesylate · Intervention Types: Drug, Drug, Drug, Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomisation until progression per recist 1.1 as assessed by the investigator, or death due to any cause (anticipated to be up to 26 months)
Closest Location: Research Site · Austin, TX
Photo of Austin 1Photo of Austin 2Photo of Austin 3
1900First Recorded Clinical Trial
96 TrialsResearching Breast Cancer
2957 CompletedClinical Trials

Who is running the clinical trial?

Daiichi Sankyo, Inc.Industry Sponsor
348 Previous Clinical Trials
335,744 Total Patients Enrolled
15 Trials studying Breast Cancer
12,893 Patients Enrolled for Breast Cancer
AstraZenecaLead Sponsor
3,935 Previous Clinical Trials
91,864,916 Total Patients Enrolled
155 Trials studying Breast Cancer
1,233,901 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have HER2 negative by IHC or negative by in situ hybridisation.
You have metastatic or locally recurrent inoperable breast cancer.
You have tumour cells that are negative for progesterone receptor on IHC.
Positive for ER on IHC.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.