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Dato-DXd for Breast Cancer

Research Site, San Juan, Philippines
Dato-DXd +5 morePhase 3RecruitingResearch Sponsored by AstraZeneca

Study Summary

This trial is testing a new cancer treatment against the current best treatment for a particular type of aggressive breast cancer, to see if the new treatment is more effective and has fewer side effects.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You cannot receive treatment with PD-1/PD-L1 inhibitor therapy.
You may be included in the study if you had a history of treated spinal cord compression or inactive brain metastases.
You are expected to live for at least 12 more weeks.
Both males and females are eligible.


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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression Free Survival (PFS)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Immunogenicity of Dato-DXd
+11 more

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dato-DXdExperimental Treatment1 Intervention
Arm 1: Dato-DXd
Group II: Investigator's Choice of Chemotherapy (ICC)Active Control5 Interventions
Arm 2: If no prior taxane, or prior taxane in the (neo)adjuvant setting and DFI > 12 months, paclitaxel or nab-paclitaxel If prior taxane and DFI ≤ 12 months: capecitabine, carboplatin, or eribulin.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,181 Previous Clinical Trials
289,629,706 Total Patients Enrolled
170 Trials studying Breast Cancer
1,245,403 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Industry Sponsor
380 Previous Clinical Trials
361,091 Total Patients Enrolled
25 Trials studying Breast Cancer
18,145 Patients Enrolled for Breast Cancer

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05374512 — Phase 3
Breast Cancer Research Study Groups: Dato-DXd, Investigator's Choice of Chemotherapy (ICC)
Breast Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT05374512 — Phase 3
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374512 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please elaborate on any potential risks associated with Dato-DXd?

"Dato-DXd is classified as a Phase 3 trial medication, so it has received a 3 for safety. This decision was made because there is both efficacy and safety data available."

Answered by AI

How many different facilities are responsible for administering this clinical trial?

"There are a total of 48 clinical trial sites for this medication, which are situated in locations such as Greenfield Park, Montreal, and Miami. If you are selected for the trial, it would be ideal to choose a location close to you to reduce travel demands."

Answered by AI

How many people fit the criteria to be a part of this test group?

"The information available on clinicaltrials.gov indicates that this trial is still enrolling patients. This study was first announced on May 16th, 2022 and was last updated on October 26th, 2022. The researchers are looking for 600 individuals to participate across 48 different sites."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
British Columbia
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
~343 spots leftby Dec 2025