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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior chemotherapy or targeted systemic therapy for metastatic or locally recurrent inoperable breast cancer
Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom 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
No Placebo-Only Group
Pivotal Trial
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 belowSelect...
You cannot receive treatment with PD-1/PD-L1 inhibitor therapy.
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You may be included in the study if you had a history of treated spinal cord compression or inactive brain metastases.
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You are expected to live for at least 12 more weeks.
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Both males and females are eligible.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
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 moreAwards & 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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have uncontrolled or serious heart problems.You are currently receiving treatment for cancer, in addition to this study.You had a major surgery or significant injury within the past 3 weeks before starting the study.Both males and females are eligible.You have a medical condition that would make it difficult for you to participate in the study or follow the study's rules.You have had another type of cancer, but it was treated and there is no sign of it now, or it has been more than 3 years since you had it.You are allergic to Dato DXd or any of its ingredients.You recently received a live vaccine within one month before starting the study treatment.You are taking long-term corticosteroids or other medications that suppress your immune system.You cannot receive treatment with PD-1/PD-L1 inhibitor therapy.You have a serious eye condition affecting the cornea.You have been tested for HER2 and the results show that you do not have high levels of the HER2 protein.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.You have not received any chemotherapy or targeted therapy for breast cancer that has spread or cannot be surgically removed.Pembrolizumab is not approved for use in your country at the time of screening.You have a tumor that can be measured and has not been treated with radiation before. The tumor must be at least 10mm in size (except for lymph nodes which must be 15mm) and can be accurately measured with CT or MRI scans.Your overall physical health is good or slightly limited, and you have not experienced any decline in the past 2 weeks.Your breast cancer doesn't have a specific protein called PD-L1, or you have previously received treatment with a PD-1/PD-L1 inhibitor and your cancer has come back.
Research Study Groups:
This trial has the following groups:- Group 1: Dato-DXd
- Group 2: Investigator's Choice of Chemotherapy (ICC)
Awards:
This trial has 2 awards, including:- 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.
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.
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
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