TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Ana C Garrido-Castro, MD
Study ID: NCT06533826
Phase: PHASE2
Status: Recruiting

Apply to this trial

Conditions

Breast Cancer
HER2-low Breast Cancer
HER2-negative Breast Cancer
Metastatic Breast Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Trastuzumab Deruxtecan — DRUG
A HER2-directed ADC, 100mg/vial, via intravenous (into the vein) infusion per protocol.
Datopotamab Deruxtecan — DRUG
A TROP2-directed antibody drug conjugate, 100mg/vial, via intravenous (into the vein) infusion per protocol.

Study Details

The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer. The names of the study drugs involved in this study are: * Datopotamab deruxtecan (a type of antibody drug conjugate) * Trastuzumab deruxtecan (a type of antibody drug conjugate)

Key Dates

Start date: Oct 29, 2024
Status verified: Oct 2025
Primary completion: Jan 1, 2028
Completion: Aug 1, 2038

Study Design

Enrollment: 357 participants (estimated)
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Arms

Experimental: Arm A (ADC1 T-DXd HR+)
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.
Experimental: Arn B (ADC1 T-DXd HR-)
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.
Experimental: Arm C (ADC1 Dato-DXd HR+)
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.
Experimental: Arm D (ADC1 Dato-DXd HR-)
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.
Experimental: Arm E (ADC2 Dato-DXd HR+)
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.
Experimental: Arm F (ADC2 Dato-DXd HR-)
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.
Experimental: Arm G (ADC2 T-DXd HR+)
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.
Experimental: Arm H (ADC2 T-DXd HR-)
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.

Primary Outcome Measure

Objective Response Rate in ADC1 (Group 1) Cohort [ Time Frame: The observation period related to this endpoint is up to 36 months. ]

Central Contacts

Ana Garrido-Castro, MD
617-632-3800
[email protected]

Locations (11)

Facility	City	State	ZIP	Site coordinators
University of Alabama	Birmingham	Alabama	35294	Humaira Sarfraz, MD [email protected] Humaira Sarfraz, MD (PRINCIPAL_INVESTIGATOR)
University of San Francisco	San Francisco	California	94158	Laura Huppert, MD [email protected] Laura Huppert, MD (PRINCIPAL_INVESTIGATOR)
Yale University Cancer Center	New Haven	Connecticut	06520	Maryam Lustberg, MD, MPH [email protected] Maryam Lustberg, MD, MPH (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical Center	Washington D.C.	District of Columbia	20007	Candace Mainor, MD [email protected] Candace Mainor, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical Center	Chicago	Illinois	60637	Nan Chen, MD [email protected] Nan Chen, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	Shana Berwick, MD [email protected] Shana Berwick, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Ana Garrido-Castro, MD 617-632-3800 Ana Garrido-Castro, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Einstein Comprehensive Cancer Center	The Bronx	New York	10461	Jesus Anampa, MD [email protected] Jesus Anampa, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina	Chapel Hill	North Carolina	27599	Yara Abdou, MD [email protected] Yara Abdou, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt Cancer Center	Nashville	Tennessee	37232	Vandana G Abramson, MD [email protected] Vandana Abramson, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of Medicine	Houston	Texas	77030	Ahmed Elkhanany, MD [email protected] Ahmed Elkhanany, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition

Breast cancer

By specialty

Oncology Breast oncology Women's health

By research site

University of Alabama· Birmingham, AL University of San Francisco· San Francisco, CA Yale University Cancer Center· New Haven, CT Georgetown University Medical Center· Washington D.C., DC University of Chicago Medical Center· Chicago, IL Beth Israel Deaconess Medical Center· Boston, MA

Related Studies

Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
Collecting Tissue Samples for Future Research From Women Undergoing Surgery for Breast Cancer
Recruiting · Northwestern University · Chicago, Illinois
Collecting and Storing Tissue Samples From Women With or Without Breast Cancer
Recruiting · Vanderbilt-Ingram Cancer Center · Nashville, Tennessee
Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
Recruiting · UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina