Trastuzumab Deruxtecan + SRS for Breast Cancer with Brain Metastases

MA
CM
Overseen ByCarla Munevar Sumarriva
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Baptist Health South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for HER-2 positive breast cancer that has spread to the brain. Researchers aim to determine if combining Trastuzumab Deruxtecan, a cancer-fighting drug, with stereotactic radiosurgery (SRS), a targeted radiation method, can better control these brain metastases. Individuals recently diagnosed with up to 10 small brain metastases and HER-2 positive breast cancer may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative combination therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does prohibit the use of anthracyclines while participating. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that the combined use of Trastuzumab Deruxtecan and Stereotactic Radiosurgery is likely to be safe?

Research has shown that combining Trastuzumab Deruxtecan (T-DXd) with stereotactic radiosurgery (SRS) is generally well-tolerated by patients with HER2-positive breast cancer that has spread to the brain. This treatment combination has improved control over brain metastases.

However, limited information exists on the safety of using T-DXd with SRS. Previous studies reported side effects, such as lung problems like interstitial lung disease (ILD) and pneumonitis, which can occur at different times.

Overall, while this combination appears promising, more research is needed to fully understand its safety. Participants might experience side effects, but these studies ensure careful monitoring of any risks.12345

Why are researchers excited about this trial's treatments?

Trastuzumab Deruxtecan is unique because it combines an antibody specifically targeting HER2-positive cancer cells with a potent chemotherapy drug, delivering treatment directly to where it's needed most. This is different from standard treatments like whole brain radiation or traditional chemotherapy, which can affect healthy cells and cause significant side effects. Researchers are excited about this treatment because it offers the potential for a more precise and effective attack on breast cancer cells that have spread to the brain, with possibly fewer side effects compared to traditional treatments.

What evidence suggests that the combination of Trastuzumab Deruxtecan and SRS could be effective for breast cancer with brain metastases?

Research has shown that Trastuzumab Deruxtecan (T-DXd) holds promise for treating HER2-positive breast cancer that has spread to the brain. One study significantly helped 73.3% of patients with brain metastases using T-DXd. Another study found T-DXd very effective in real-world settings, reducing brain tumors in 71% of women with metastatic breast cancer. In this trial, all participants will receive both T-DXd and Stereotactic Radiosurgery (SRS) to evaluate safety and determine an appropriate dose. These findings suggest that T-DXd could effectively control breast cancer that spreads to the brain.678910

Who Is on the Research Team?

MA

Manmeet Ahluwalia

Principal Investigator

Miami Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with HER2-positive breast cancer that has spread to the brain (1-10 tumors, each 3 cm or less). Participants must have good organ function, not be pregnant or breastfeeding, and be able to undergo MRI. People with certain eye issues, heart problems, prior cranial radiation, or other serious illnesses cannot join.

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
See 13 more

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.
See 17 more

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

Trial Overview

The study tests a combination of stereotactic radiosurgery (a precise form of brain radiation) and Trastuzumab Deruxtecan (T-DXd), an investigational drug. The goal is to see how well this combo controls brain metastases in HER2+ breast cancer patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: T-DXd + SRSExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials
54
Recruited
8,100+

National Brain Tumor Society

Collaborator

Citations

Trastuzumab deruxtecan in patients with active brain ... - PMC

In conclusion, T-DXd yields clinically intracranial activity in previously treated patients with HER2-positive/low MBC with active BMs and ...

Real life outcome analysis of breast cancer brain ...

This study confirmed the high intracranial efficacy and manageable safety profile of T-DXd in this first-ever real world analysis.

low metastatic breast cancer with brain metastases (BCBM) ...

Background: Accumulating data demonstrate both overall and intracranial activity of Trastuzumab deruxtecan (T-DXd) in HER2 positive breast ...

T-DXd Shows Real-World Efficacy in HER2+ and HER2 ...

T-DXd demonstrated durable systemic and intracranial responses in patients with HER2-positive, -low, and -zero breast cancer brain metastases.

Trastuzumab deruxtecan in advanced breast cancer ...

Trastuzumab deruxtecan showed superior intracranial overall response rate (ORR) and median progression-free survival (mPFS) than controls in both stable and ...

Impact of trastuzumab deruxtecan (T-DXd) and brain ... - PMC

This study evaluated the safety and efficacy of T-DXd and SRS in patients with HER2-positive or -low breast cancer brain metastases (BCBM). Methods. We ...

Multi-institutional report of trastuzumab deruxtecan and ...

Trastuzumab-deruxtecan (T-DXd) has demonstrated intracranial efficacy; however, safety and efficacy data remains limited with stereotactic ...

Study Details | NCT07454668 | Trastuzumab Deruxtecan + ...

Histologically confirmed HER-2-positive breast cancer with newly diagnosed brain metastases. ECOG Performance Status (PS) of 0, 1, 2. Participants with 1-10 ...

Multi-Institutional Report of Trastuzumab-Deruxtecan and ...

To report oncologic and safety outcomes of combined stereotactic radiosurgery (SRS) and the antibody drug conjugate (ADC) trastuzumab-deruxtecan (T-DXd)

Multi-Institutional Report of Trastuzumab-Deruxtecan and ...

To report oncologic and safety outcomes of combined stereotactic radiosurgery (SRS) and the antibody drug conjugate (ADC) trastuzumab-deruxtecan ...