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Anti-metabolites

Dato-DXd for Triple-negative Breast Cancer

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridisation per the ASCO-CAP HER2 guideline
Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Timeline
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)
Awards & highlights

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.

Who is the study for?
This trial is for adults with triple-negative breast cancer that's locally recurrent and inoperable or has spread (metastatic), who haven't had chemotherapy for this condition, and can't use PD-1/PD-L1 inhibitor therapy. Participants need at least one measurable tumor lesion, good physical status (ECOG PS 0 or 1), adequate organ function, a life expectancy of over 12 weeks, and must not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study compares Dato-DXd to standard chemotherapies like Paclitaxel and Nab-paclitaxel in patients with advanced triple-negative breast cancer. It's an open-label Phase III trial where participants are randomly assigned to either the test drug group or the control group receiving investigator's choice of chemotherapy.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion treatments, fatigue, hair loss (alopecia), digestive issues such as nausea and diarrhea, blood disorders like low white cell count which increases infection risk. Specific side effects from Dato-DXd may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is HER2 negative according to specific testing guidelines.
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I am using birth control as per my local guidelines.
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I have a tumor that can be measured and has not been treated with radiation.
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I have signed a consent form for optional genetic research.
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My organs and bone marrow are functioning well.
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I haven't had chemotherapy or targeted therapy for my advanced breast cancer.
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I haven't had chemotherapy or other cancer treatments for advanced breast cancer.
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My physical ability hasn't worsened in the last 2 weeks.
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My triple-negative breast cancer is inoperable or has spread and cannot be cured.
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I am 18 years old or older.
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My breast cancer is PD-L1 negative or has returned after PD-1/PD-L1 treatment.

Timeline

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

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?

Daiichi SankyoIndustry Sponsor
389 Previous Clinical Trials
409,316 Total Patients Enrolled
25 Trials studying Breast Cancer
17,027 Patients Enrolled for Breast Cancer
AstraZenecaLead Sponsor
4,243 Previous Clinical Trials
288,527,607 Total Patients Enrolled
173 Trials studying Breast Cancer
1,245,739 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
414,654 Total Patients Enrolled
27 Trials studying Breast Cancer
19,002 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
California
British Columbia
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
~286 spots leftby Dec 2025