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Antitumor Antibiotic

Dato-DXd +/− Durvalumab vs Chemotherapy + Pembrolizumab 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

All participants must provide a FFPE metastatic or locally recurrent inoperable tumour sample

Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomisation until progression per recist 1.1 as assessed by bicr, or death due to any cause (anticipated to be up to 33 months).

Awards & highlights

Study Summary

This trial studies new treatments for advanced triple-negative breast cancer.

Who is the study for?

This trial is for adults with PD-L1 positive triple-negative breast cancer that's locally recurrent and inoperable or has spread (metastatic). They should not have had prior chemo or targeted therapy for their advanced disease, must have measurable disease per specific criteria, and proper organ function. Participants need to agree to use contraception if they can have children.Check my eligibility

What is being tested?

The study compares the effectiveness of Dato-DXd alone or combined with Durvalumab against standard chemotherapy paired with Pembrolizumab. It's a Phase III trial where patients are randomly assigned to one of these three treatment groups to see which works best.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, fatigue, blood disorders like anemia or clotting issues, potential liver problems and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can provide a tissue sample from my cancer that cannot be removed by surgery.

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I am eligible for chemotherapy with paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin.

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My triple-negative breast cancer is PD-L1 positive with a CPS of 10 or more.

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I haven't had chemotherapy or targeted therapy for advanced breast cancer.

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My breast cancer is advanced and cannot be removed by surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomisation until progression per recist 1.1 as assessed by bicr, or death due to any cause (anticipated to be up to 33 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomisation until progression per recist 1.1 as assessed by bicr, or death due to any cause (anticipated to be up to 33 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation until progression per recist 1.1 as assessed by bicr, or death due to any cause (anticipated to be up to 33 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

Progression Free Survival (PFS)

Secondary outcome measures

Clinical Benefit Rate (CBR) at 24 weeks

Duration of Response (DoR)

Immunogenicity of Dato-DXd in combination with durvalumab

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Dato-DXd + durvalumabExperimental Treatment2 Interventions

Arm 1: Dato-DXd + durvalumab

Group II: Dato-DXdExperimental Treatment1 Intervention

Arm 3: Dato-DXd

Group III: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumabActive Control5 Interventions

Arm 2: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

419,533 Total Patients Enrolled

27 Trials studying Breast Cancer

18,977 Patients Enrolled for Breast Cancer

Daiichi SankyoIndustry Sponsor

392 Previous Clinical Trials

415,601 Total Patients Enrolled

25 Trials studying Breast Cancer

17,002 Patients Enrolled for Breast Cancer

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,611,975 Total Patients Enrolled

173 Trials studying Breast Cancer

1,245,714 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.

Has the FDA sanctioned Dato-DXd + durvalumab for clinical use?

"Due to the available evidence, our team at Power has assigned Dato-DXd + durvalumab a safety rating of 3 - reflecting that there is empirical data attesting its efficacy and multiple rounds confirming its security."

Answered by AI

Is enrollment still available for this research trial?

"The data viewable on clinicaltrials.gov indicates that this research trial is not presently enrolling patients, despite being initially posted back in November 15th 2023 and last updated October 23rd of the same year. Nevertheless, 2810 other trials are currently recruiting volunteers to participate."

Answered by AI

How many venues are being utilized for the administration of this research endeavor?

"Currently, 94 trial sites are welcoming applicants for this clinical study. Examples of the participating cities include Glendale, Santa Rosa and New Haven alongside a further 91 locations. To minimize travel commitments it is suggested to pick a nearby site if you wish to partake in the procedure."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

2023. "A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06103864.

All > Breast Cancer Albuquerque > Honolulu