DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Part of paid clinical trials in Miami, Florida.

Sponsor
Sarah Sammons, MD
Study ID
NCT06176261
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer
  • Breast Cancer Female
  • ER Positive Breast Cancer
  • ER-negative Breast Cancer
  • HER2 Negative Breast Carcinoma
  • HER2-negative Breast Cancer
  • Metastatic Triple-Negative Breast Carcinoma

Eligibility Criteria

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

Interventions

  • Datopotamab Deruxtecan — DRUG
    Antibody-drug conjugate, 100 mg single-use vial, via intravenous infusion per protocol.

Study Details

The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain. The name of the study drug used in this research study is: Datopotamab deruxtecan (a type of antibody-drug conjugate)

Key Dates

Start date
Jan 8, 2024
Status verified
Jul 2025
Primary completion
Jan 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort B: Metastatic Triple-Negative Breast Cancer
    24 participants will be enrolled and will complete study procedures as outlined below: * Baseline visit with optional CSF collection via lumbar puncture and assessments. * CT or MRI scans every 6 weeks for 24 weeks, then every 9 weeks. * Cycle 1 Through End of Treatment: --Day 1 of 21 day cycle: Predetermined dose of Datopotamab Deruxtecan 1x daily. * End of Treatment: * Follow up every 6 months. * Optional CSF collection via lumbar puncture. * CT or MRI scans every 12 weeks.
  • Experimental: Cohort C: HER2-Negative Metastatic Breast Cancer (any ER Expression) with Leptomeningeal Metastases
    * Baseline visit with CSF collection via lumbar puncture and assessments. * CT or MRI scans every 6 weeks for 24 weeks, then every 9 weeks. * Cycle 1 --Day 1 of 21 day cycle: Predetermined dose of Datopotamab Deruxtecan 1x daily. * Cycle 2 * Day 1 of 21 day cycle: Predetermined dose of Dato-DXd 1x daily. * Day 2 of 21 day cycle: CSF collection. * Cycle 3 Through End of Treatment: --Day 1 of 21 day cycle: Predetermined dose of Datopotamab Deruxtecan 1x daily. * End of Treatment: * Follow up every 6 months. * Optional CSF collection via lumbar puncture. * CT or MRI scans every 12 weeks.
  • Experimental: Cohort A: Estrogen Receptor Positive HER2-Negative Metastatic Breast Cancer
    24 participants will be enrolled and will complete study procedures as outlined below: * Baseline visit with optional CSF collection via lumbar puncture and assessments. * CT or MRI scans every 6 weeks for 24 weeks, then every 9 weeks. * Cycle 1 Through End of Treatment: --Day 1 of 21 day cycle: Predetermined dose of Datopotamab Deruxtecan 1x daily. * End of Treatment: * Follow up every 6 months. * Optional CSF collection via lumbar puncture. * CT or MRI scans every 12 weeks.

Primary Outcome Measure

Objective Response Rate (ORR) in RANO-BM Criteria [ Time Frame: 3 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Miami Baptist Cancer Institute/MiamiFlorida33176
Manmeet Ahluwalia, MD
[email protected]
786-527-8010
Manmeet Ahluwalia, MD (SUB_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Sarah Sammons, MD
[email protected]
617-362-3800
Sarah Sammons, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Danielle Brander, MD
[email protected]
Peggy Alton, RN
[email protected]
919-681-4769

Find similar trials in Miami, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Miami Baptist Cancer Institute/· Miami, FLDana-Farber Cancer Institute· Boston, MADuke University Medical Center· Durham, NC

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