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Monoclonal Antibodies

Dato-DXd + Durvalumab for 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

Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer

ECOG PS of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cycle 1 day 1 of neoadjuvant treatment until pre-surgery safety fu visit (for approximately 24 weeks) or eot - whichever occurs first, and then from cycle 1 day 1 of adjuvant treatment until eot (for approximately 27 weeks).

Awards & highlights

Study Summary

This trial tests the effectiveness and safety of new treatments for TNBC and hormone receptor-low/HER2-negative breast cancer.

Who is the study for?

Adults over 18 with Stage II or III breast cancer that's triple-negative or hormone receptor-low/HER2-negative can join. They need good bone marrow and organ function, an ECOG performance status of 0 or 1, a tumor sample for testing, and must follow local contraception rules.Check my eligibility

What is being tested?

The study compares two treatments: Dato-DXd plus durvalumab (with/without chemo) versus pembrolizumab plus chemotherapy (with/without more chemo), both before and after surgery in patients who haven't had prior treatment for their breast cancer.See study design

What are the potential side effects?

Possible side effects include immune-related reactions, fatigue, nausea, hair loss from chemotherapy drugs like Paclitaxel and Doxorubicin; heart issues from Epirubicin; blood cell count changes; potential kidney damage from Carboplatin.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is confirmed to be at Stage II or III and is either triple-negative or has low hormone receptors and is HER2-negative.

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

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free survival (EFS) in the experimental vs control arms

Pathologic Complete Response (pCR) in the experimental vs control arms

Secondary outcome measures

Distant disease-free survival (DDFS) in the experimental vs control arms

Immunogenicity of Dato-DXd (in combination with durvalumab)

Overall Survival (OS) in the experimental vs control arms

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dato-DXd plus durvalumabExperimental Treatment9 Interventions

Participants receive durvalumab every 3 weeks (Q3W) + Dato-DXd Q3W as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvaluamb Q3W as adjuvant therapy post-surgery. Adjuvant chemotherapy may be given in combination with durvalumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease Adjuvant chemotherapy may be one of these: Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) and carboplatin (weekly or Q3W) for 4 cycles (12 weeks); Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks); Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks); Capecitabine (Q3W) for 8 cycles.

Group II: Pembrolizumab plus chemotherapyActive Control8 Interventions

Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Adjuvant capecitabine (Q3W) for 8 cycles may be given in combination with pembrolizumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Capecitabine

2013

Completed Phase 3

~3420

Doxorubicin

2012

Completed Phase 3

~7940

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Epirubicin

2012

Completed Phase 4

~19470

Durvalumab

2017

Completed Phase 2

~3870

Olaparib

2007

Completed Phase 4

~2140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

418,430 Total Patients Enrolled

27 Trials studying Breast Cancer

17,874 Patients Enrolled for Breast Cancer

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,610,872 Total Patients Enrolled

173 Trials studying Breast Cancer

1,244,611 Patients Enrolled for Breast Cancer

Daiichi SankyoIndustry Sponsor

392 Previous Clinical Trials

414,498 Total Patients Enrolled

25 Trials studying Breast Cancer

15,899 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.

Does the FDA recognize Dato-DXd in combination with durvalumab as a viable treatment?

"Our team has assigned a score of 3 to the safety profile of Dato-DXd plus durvalumab, due to existing evidence from Phase 3 trials displaying both efficacy and repeated guarantee of safety."

Answered by AI

How many areas are hosting this clinical exploration?

"Patients can join this clinical trial at 128 different sites, located in Jonesboro, Rogers and Los Angeles as well as 125 other cities. To reduce the burden of travel it is suggested that you choose a clinic near to your own location."

Answered by AI

Are there still opportunities available to participate in this research initiative?

"According to the information posted on clinicaltrials.gov, this trial has ceased recruitment and is no longer seeking participants. It was initially listed on November 15th 2023 and last updated October 31st of that same year. However, those interested may find solace in knowing that there are over 2700 other medical studies actively enrolling patients at this time."

Answered by AI

What ambitious goals does this research endeavor aim to accomplish?

"The central aim of this trial is to assess Event-free Survival (EFS) in the experimental and control arms over a specified timeline. Other secondary outcomes that will be evaluated include Distant Disease-Free Survival (DDFS), Participant-reported Breast & Arm Symptoms, and Physical Function Scores measured by the PROMIS Short Form 8c. Data analysis will encompass all randomised participants regardless of whether they withdraw or receive alternative therapy. Hazard Ratios for DDFS as well as mean between arm differences in other metrics are included among the measures of interest."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

2023. "A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112379.

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