Trastuzumab Deruxtecan + SRS for Breast Cancer with Brain Metastases

Overseen By Carla Munevar Sumarriva

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Baptist Health South Florida

Must not be taking: Anthracyclines

Disqualifiers: Leptomeningeal metastases, Cardiac disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Manmeet Ahluwalia

Principal Investigator

Miami Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Hemoglobin ≥ 9 g/dL, White blood count ≥ 3.0 × 10^9/L, Absolute Neutrophil count ≥ 1.5 × 10^9/L, and platelet count ≥ 100 × 10^9/L

I have 1 to 10 brain tumors, each 3 cm or smaller.

Signed written informed consent by patient or legally authorized representative obtained prior to any study-specific procedures

Exclusion Criteria

My brain metastases are within 5 mm of my optic nerve or optic chiasm.

Pregnant or breast feeding. The patients should not breastfeed for 7 months after stopping the drug

I will not use anthracycline drugs during this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Radiosurgery (SRS) combined with Trastuzumab Deruxtecan (T-DXd) to evaluate safety and determine an appropriate dose

3 weeks

Visits as per dose administration schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of dose-limiting toxicities and progression-free survival

6 months

Regular follow-up visits for assessments

Long-term follow-up

Participants are monitored for overall survival and objective response rate

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Radiosurgery
• Trastuzumab Deruxtecan

How Is the Trial Designed?

Group I: T-DXd + SRS Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

National Brain Tumor Society

Collaborator