Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06176261

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

Led by Sarah Sammons, MD · Updated on 2025-07-30

58

Participants Needed

3

Research Sites

260 weeks

Total Duration

On this page

Sponsors

S

Sarah Sammons, MD

Lead Sponsor

D

Daiichi Sankyo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Metastatic breast cancer confirmed to be HER2-negative by 2018 ASCO/CAP guidelines
  • Radiological confirmation of metastatic disease
  • Cohorts A and B: Newly diagnosed or progressing brain metastases after prior therapy
  • Cohorts A and B: Baseline brain MRI with measurable CNS metastasis ≥ 1.0 cm, or head CT if MRI contraindicated
  • Cohort C: Radiological and clinical evidence of leptomeningeal disease
  • Cohort A: Prior progression after at least one line of endocrine treatment for metastatic disease
  • Cohorts B and C: No prior treatment required
  • Measurable or non-measurable extracranial disease allowed; imaging required at baseline
  • Age 18 years or older
  • ECOG performance status 0-2
  • Adequate treatment washout periods before registration
  • Left ventricular ejection fraction ≥ 50%
  • Adequate organ function including specific blood counts, liver and kidney function
  • Female participants of childbearing potential must have negative pregnancy test within 14 days
  • Ability and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Visceral crisis or impending visceral crisis
  • CNS complications requiring urgent neurosurgical intervention
  • Need for immediate local therapy to CNS lesions
  • Significant symptomatic intracranial hemorrhage
  • More than 2 seizures within 4 weeks before study entry
  • Ongoing toxicities from prior cancer therapy not improved to Grade ≤ 1 except alopecia
  • Contraindications to MRI preventing imaging (except CT for cohorts A and B if applicable)
  • Concurrent use of other anti-cancer therapies during study
  • Uncontrolled illnesses including active infection, severe heart or lung disease, recent heart attack, ulcers, chronic liver or kidney disease, or severe malnutrition
  • Need for systemic corticosteroids >4 mg daily dexamethasone or immunosuppressive meds within 7 days before baseline MRI
  • History or current interstitial lung disease or pneumonitis requiring steroids or suspected by imaging
  • History of uncontrolled seizures, CNS disorders, or psychiatric conditions affecting compliance
  • History of other malignancies except certain treated cancers with no disease for ≥ 3 years
  • Major surgery or trauma within 28 days before treatment or planned during study
  • Clinically significant corneal disease
  • History of severe hypersensitivity to study drug or monoclonal antibodies
  • Pregnant or breastfeeding women
  • Female participants must be post-menopausal, surgically sterile, or use effective birth control if of childbearing potential
  • Restrictions on ova donation and breastfeeding during and after study
  • Male participants sexually active with females of childbearing potential must be sterile or use contraception and avoid sperm donation during and after study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Miami Baptist Cancer Institute/

Miami, Florida, United States, 33176

Actively Recruiting

2

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

3

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

S

Sarah Sammons, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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