Trastuzumab Deruxtecan + Stereotactic Radiosurgery (SRS) in HER2+ Breast Cancer Brain Metastases

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT07454668
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab Deruxtecan — DRUG
    T-DXd will be given as an IV infusion every 21 days. This Phase 1 study will use predefined dose levels (5.4 mg/kg, 4.4 mg/kg, and 3.2 mg/kg) to evaluate safety and tolerability. Participants may continue treatment until disease progression, unacceptable side effects, or withdrawal.
  • Stereotactic Radiosurgery — RADIATION
    Participants will receive SRS to intact brain metastases. Typical dosing is 20-24 Gy in a single fraction for lesions \<20 mm, or 27 Gy in 3 fractions for lesions ≥20 mm. Exact dosing will be based on the treating radiation oncologist's clinical judgment.

Study Details

A phase I clinical trial (a type of research study) for people with human epidermal growth factor receptor 2 (HER-2) positive breast cancer with metastasis to the brain. This research study will evaluate how well brain metastases can be controlled using a type of radiation therapy known as stereotactic radiosurgery (SRS) when combined with the therapeutic agent Trastuzumab Deruxtecan (T-DXd). The combined use of SRS with T-DXd is considered investigational.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: T-DXd + SRS
    All participants will receive SRS and the drug T-DXd. The goal is to evaluate safety and determine an appropriate dose.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Manmeet Ahluwalia, MD
[email protected]
786-596-2000
Carla Munevar Sumarriva
[email protected]
786-596-2000

Find similar trials in Miami, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Miami Cancer Institute at Baptist Health, Inc.· Miami, FL

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