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Antibody-drug conjugate
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
Participant must be ≥ 18 years at the time of screening.
Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to date of death, due to any cause, up to 87 months from first subject in
Awards & highlights
Study Summary
This trial will study a new cancer treatment for those with advanced breast cancer after neoadjuvant therapy.
Who is the study for?
Adults over 18 with stage I-III triple-negative breast cancer who didn't have a complete response after neoadjuvant therapy. They must have finished at least 6 cycles of specific chemotherapy, had surgery to remove the disease, and can't be in relapse. Participants need good heart function and overall health but can't join if they've had certain severe diseases, other cancers within 5 years, or known genetic mutations related to breast cancer.Check my eligibility
What is being tested?
The study is testing Dato-DXd alone or combined with Durvalumab against standard treatments chosen by the investigator for patients with triple-negative breast cancer post-surgery. It's an open-label trial where everyone knows which treatment they're getting, and it involves multiple international centers.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs, infusion-related symptoms like fever or chills, fatigue, gastrointestinal issues such as diarrhea or nausea, blood disorders leading to increased risk of infections or bleeding problems. Specific side effects depend on each drug's profile.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My breast cancer is triple-negative, confirmed by a biopsy.
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I still have cancer in my breast or lymph nodes after initial treatment.
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I've completed 6+ cycles of specific chemo before surgery for my cancer.
Select...
My cancer has not returned or spread after treatment.
Select...
I had surgery to remove all visible cancer from my breast and lymph nodes.
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I can provide a tissue sample from my cancer surgery for analysis.
Select...
I have not received any additional treatment after my primary cancer treatment.
Select...
I do not have a known BRCA1 or BRCA2 gene mutation.
Select...
My organs and bone marrow are working well.
Select...
I am 18 years old or older.
Select...
My breast cancer is triple-negative, confirmed by a biopsy.
Select...
I still have cancer in my breast or lymph nodes after initial treatment.
Select...
I've completed 6 cycles of specific chemotherapy for my cancer.
Select...
My cancer has not returned or spread after treatment.
Select...
I had surgery to remove all visible cancer from my breast and lymph nodes.
Select...
I can provide a tissue sample from my surgery for analysis.
Select...
I have not received any additional treatment after my primary cancer treatment.
Select...
I do not have a known BRCA1 or BRCA2 gene mutation.
Select...
My organs and bone marrow are working well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization to date of death, due to any cause, up to 87 months from first subject in
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to date of death, due to any cause, up to 87 months from first subject in
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT
Secondary outcome measures
DDFS for Dato-DXd + durvalumab vs Dato-DXd
DDFS for Dato-DXd vs ICT
Distant disease-free survival (DDFS) for Dato-DXd + durvalumab vs ICT
+10 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Dato-DXd in combination with DurvalumabExperimental Treatment2 Interventions
Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles
Group II: Dato-DXdExperimental Treatment1 Intervention
Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles
Group III: Investigators Choice TherapyActive Control2 Interventions
Arm 3: Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles
Pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles
Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles + pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles
* Only participants who have received prior pembrolizumab in the neoadjuvant setting should receive pembrolizumab as part of their adjuvant therapy on Arm 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
SWOG Clinical Trials PartnershipUNKNOWN
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
419,083 Total Patients Enrolled
27 Trials studying Breast Cancer
18,527 Patients Enrolled for Breast Cancer
SWOG Clinical Trials PartnershipsUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any additional treatment after my primary cancer treatment.I am 18 years old or older.I can provide a tissue sample from my surgery for analysis.I do not have an active tuberculosis infection.I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.I have not received any additional treatment after my primary cancer treatment.I have completed any needed radiotherapy before starting this study.I do not have a known BRCA1 or BRCA2 gene mutation.My cancer has not returned or spread after treatment.I am 18 years old or older.I still have cancer in my breast or lymph nodes after initial treatment.I can care for myself and have not gotten worse in the past 2 weeks.I have a serious eye condition affecting my cornea.I have an active liver disease.I have moderate to severe nerve damage in my hands or feet.I have been treated with a PD-1/PD-L1 inhibitor, but not pembrolizumab.My breast cancer is triple-negative, confirmed by a biopsy.My last radiation was less than 6 weeks ago, or my surgery was less than 16 weeks ago.I haven't taken immunosuppressive drugs in the last 14 days.I have or had an autoimmune or inflammatory disorder.I can provide a tissue sample from my cancer surgery for analysis.I have severe lung problems due to another lung condition.I am eligible for a treatment option chosen by my doctor.I had cancer before, but it was either skin cancer treated by removal, a contained cancer cured by treatment, or another type of cancer that has been in remission for over 5 years.I do not have severe illnesses, recent organ transplants, bleeding issues, infections, or chronic diarrhea.I have lasting side effects from cancer treatment, but they're not expected to worsen with this study.I do not have active or uncontrolled hepatitis B or C.I've completed 6 cycles of specific chemotherapy for my cancer.My cancer has not returned or spread after treatment.I had surgery to remove all visible cancer from my breast and lymph nodes.My physical health has been stable or better for the last 2 weeks.I have had breast cancer before or it came back after initial treatment.My breast cancer has spread to other parts of my body.My organs and bone marrow are working well.I have completed any needed radiotherapy before starting this study.I do not have a known BRCA1 or BRCA2 gene mutation.I do not have any major heart problems.My organs and bone marrow are working well.My breast cancer is triple-negative, confirmed by a biopsy.I still have cancer in my breast or lymph nodes after initial treatment.I've completed 6+ cycles of specific chemo before surgery for my cancer.I had surgery to remove all visible cancer from my breast and lymph nodes.My last radiation was less than 6 weeks ago, or my surgery was less than 16 weeks ago.I am eligible for a treatment option chosen by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Dato-DXd in combination with Durvalumab
- Group 2: Investigators Choice Therapy
- Group 3: Dato-DXd
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this research endeavor available to me?
"Those applying for this clinical trial must have breast cancer and be between the ages of 18-130. Around 1075 participants are being sought."
Answered by AI
In what locales is this exploration of treatments occurring?
"This clinical trial is currently running at 36 diverse medical sites, including locations in New york City, North Vancouver and Iowa. For your convenience, it's best to select the closest centre so as to limit travelling demands."
Answered by AI
Is there any availability for volunteers in this experiment?
"The clinical trial has ceased recruitment of participants, as per information on the website of clinicaltrials.gov - it was initially posted November 30th 2022 and lastly updated November 17th 2022. Nevertheless, there are presently 2,665 other medical trials which are still taking in patients."
Answered by AI
Does the trial encompass participants aged eighty-five and over?
"This medical study is in search of individuals who are aged 18 or older and younger than 130."
Answered by AI
Has the FDA sanctioned the use of a Dato-DXd and Durvalumab joint therapy yet?
"Our Power team has rated the safety of Dato-DXd in conjunction with Durvalumab a 3 due to existing evidence for both efficacy and safeguards that have been established during the Phase 3 trial."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I want u guys help em new medicine , thank u.
PatientReceived 1 prior treatment
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