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Antibody Drug Conjugate
Dato-DXd + T-DXd for Breast Cancer (TRADE DXd Trial)
Phase 2
Waitlist Available
Led By Ana Garrido-Castro, MD
Research Sponsored by Ana C Garrido-Castro, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The subject is ≥ 18 years old.
The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2 in a CLIA-certified environment. ER, PR and HER2 status per local testing must be known prior to study registration.
Must not have
Known HIV infection that is not well controlled.
Women who are pregnant or breastfeeding or planning to become pregnant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the observation period related to this endpoint is up to 5 years.
Awards & highlights
Summary
"This trial aims to test the safety and effectiveness of two experimental drugs (datopotamab deruxtecan followed by trastuzumab deruxtecan, or vice versa) in treating
Who is the study for?
This trial is for individuals with HER2-low metastatic breast cancer. Participants should be those whose cancer has not responded to previous treatments (ADC-refractory). Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior therapies.
What is being tested?
The study tests the safety and effectiveness of two drugs: Datopotamab Deruxtecan and Trastuzumab Deruxtecan. It explores whether using these drugs in sequence can treat this type of breast cancer effectively.
What are the potential side effects?
While specific side effects aren't listed here, antibody drug conjugates like those being tested may cause fatigue, nausea, hair loss, low blood cell counts increasing infection risk or bleeding problems, and potential heart or lung issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My latest cancer test results for ER, PR, and HER2 are available from a certified lab.
Select...
My breast cancer is HER2-low.
Select...
My HR-positive breast cancer has worsened despite endocrine therapy and CDK4/6 inhibitor treatment.
Select...
I am fully active or able to carry out light work.
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My heart's pumping ability is normal or above.
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My breast cancer is advanced and cannot be removed by surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My HIV infection is not well controlled.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant.
Select...
I have not had major surgery in the last 2 weeks.
Select...
I have or had lung inflammation that needed steroids.
Select...
I do not have any serious lung illnesses besides my cancer.
Select...
I do not have active or uncontrolled hepatitis B or C.
Select...
I do not have any active infections, including tuberculosis.
Select...
I have a serious eye condition affecting my cornea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the observation period related to this endpoint is up to 5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the observation period related to this endpoint is up to 5 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate in ADC1 (Group 1) Cohort
Objective Response Rate in ADC2 (Group 2) Cohort
Secondary study objectives
Change in HER2 Expression from Baseline to Progression
Change in TROP2 Expression from Baseline to Progression
Clinical Benefit Rate (CBR) in ADC1 (Group 1) Cohort
+14 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Arn B (ADC1 T-DXd HR-)Experimental Treatment1 Intervention
Enrolled participants will complete:
* Baseline visit with tumor biopsy, imaging, electrocardiogram and echocardiogram.
* Tumor biopsy between Cycle 2 Day 1 and Day 8.
* Imaging every 9 weeks.
* Cycle 1 through end of treatment:
--Day 1 of 21 day cycle: Predetermined dose of Trastuzumab deruxtecan 1x daily.
* Cycle 4 through end of treatment:
* Day 1 of 21 day cycle: Predetermined dose of Trastuzumab deruxtecan 1x daily.
* Imaging on Day 1.
* End of Treatment visit with imaging, tumor biopsy, echocardiogram
* Follow up: imaging every 9 weeks.
* Long-term Follow Up: visits every 6 months.
Group II: Arm H (ADC2 T-DXd HR-)Experimental Treatment1 Intervention
Participants will complete:
* Baseline visit with imaging, tumor biopsy, electrocardiogram, echocardiogram.
* Imaging every 9 weeks.
* Cycle 1 through Cycle 3:
--Day 1 of 21 day cycle: Predetermined dose of Trastuzumab deruxtecan 1x daily.
* Cycle 1 through end of treatment:
* Day 1 of 21 day cycle: Predetermined dose of Trastuzumab deruxtecan 1x daily.
* Imaging on Day 1.
* End of Treatment visit with imaging, tumor biopsy, echocardiogram
* Follow up: imaging every 9 weeks.
* Long-term Follow Up: visits every 6 months.
Group III: Arm G (ADC2 T-DXd HR+)Experimental Treatment1 Intervention
Participants will complete:
* Baseline visit with imaging, tumor biopsy, electrocardiogram, echocardiogram.
* Imaging every 9 weeks.
* Cycle 1 through Cycle 3:
--Day 1 of 21 day cycle: Predetermined dose of Trastuzumab deruxtecan 1x daily.
* Cycle 1 through end of treatment:
* Day 1 of 21 day cycle: Predetermined dose of Trastuzumab deruxtecan 1x daily.
* Imaging on Day 1.
* End of Treatment visit with imaging, tumor biopsy, echocardiogram
* Follow up: imaging every 9 weeks.
* Long-term Follow Up: visits every 6 months.
Group IV: Arm F (ADC2 Dato-DXd HR-)Experimental Treatment1 Intervention
Participants will complete:
* Baseline visit with imaging, tumor biopsy, electrocardiogram, eye exam.
* Imaging every 9 weeks.
* Cycle 1 through Cycle 3:
--Day 1 of 21 day cycle: Predetermined dose of Datopotamab deruxtecan 1x daily.
* Cycle 1 through end of treatment:
* Day 1 of 21 day cycle: Predetermined dose of Datopotamab deruxtecan 1x daily.
* Imaging on Day 1.
* End of Treatment visit with imaging, tumor biopsy, eye exam.
* Follow up: imaging every 9 weeks.
* Long-term Follow Up: visits every 6 months.
Group V: Arm E (ADC2 Dato-DXd HR+)Experimental Treatment1 Intervention
Participants will complete:
* Baseline visit with imaging, tumor biopsy, electrocardiogram, eye exam.
* Imaging every 9 weeks.
* Cycle 1 through Cycle 3:
--Day 1 of 21 day cycle: Predetermined dose of Datopotamab deruxtecan 1x daily.
* Cycle 4 through end of treatment:
* Day 1 of 21 day cycle: Predetermined dose of Datopotamab deruxtecan 1x daily.
* Imaging on Day 1.
* End of Treatment visit with imaging, tumor biopsy, eye exam.
* Follow up: imaging every 9 weeks.
* Long-term Follow Up: visits every 6 months.
Group VI: Arm D (ADC1 Dato-DXd HR-)Experimental Treatment1 Intervention
Enrolled participants will complete:
* Baseline visit with tumor biopsy, imaging, electrocardiogram and eye exam.
* Tumor biopsy between Cycle 2 Day 1 and Day 8.
* Imaging every 9 weeks.
* Cycle 1 through Cycle 3:
--Day 1 of 21 day cycle: Predetermined dose of Datopotamab deruxtecan 1x daily.
* Cycle 4 through end of treatment:
* Day 1 of 21 day cycle: Predetermined dose of Datopotamab deruxtecan 1x daily.
* Imaging on Day 1.
* End of Treatment visit with imaging, tumor biopsy, eye exam.
* Follow up: imaging every 9 weeks.
* Long-term Follow Up: visits every 6 months.
Group VII: Arm C (ADC1 Dato-DXd HR+)Experimental Treatment1 Intervention
Enrolled participants will complete:
* Baseline visit with tumor biopsy, imaging, electrocardiogram and eye exam.
* Tumor biopsy between Cycle 2 Day 1 and Day 8.
* Imaging every 9 weeks.
* Cycle 1 through end of treatment:
--Day 1 of 21 day cycle: Predetermined dose of Datopotamab deruxtecan 1x daily.
* Cycle 4 through end of treatment:
* Day 1 of 21 day cycle: Predetermined dose of Datopotamab deruxtecan 1x daily.
* Imaging on Day 1.
* End of Treatment visit with imaging, tumor biopsy, eye exam.
* Follow up: imaging every 9 weeks.
* Long-term Follow Up: visits every 6 months.
Group VIII: Arm A (ADC1 T-DXd HR+)Experimental Treatment1 Intervention
Enrolled participants will complete:
* Baseline visit with tumor biopsy, imaging, electrocardiogram and echocardiogram.
* Tumor biopsy between Cycle 2 Day 1 and Day 8.
* Imaging every 9 weeks.
* Cycle 1 through Cycle 3:
--Day 1 of 21 day cycle: Predetermined dose of Trastuzumab deruxtecan 1x daily.
* Cycle 4 through end of treatment:
* Day 1 of 21 day cycle: Predetermined dose of Trastuzumab deruxtecan 1x daily.
* Imaging on Day 1.
* End of Treatment visit with imaging, tumor biopsy, echocardiogram
* Follow up: imaging every 9 weeks.
* Long-term Follow Up: visits every 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab Deruxtecan
2021
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Ana C Garrido-Castro, MDLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,452 Total Patients Enrolled
175 Trials studying Breast Cancer
1,245,221 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
25 Previous Clinical Trials
2,618 Total Patients Enrolled
14 Trials studying Breast Cancer
1,636 Patients Enrolled for Breast Cancer
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