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Radiation + HER2-targeted Therapy for Leptomeningeal Metastasis from Breast Cancer

Phase 1 & 2

Recruiting

Led By Kamran Ahmed, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recovery from surgery within 14 days and clearance by surgeon

Willingness to have an Ommaya reservoir placed and be a candidate for its placement

Must not have

Symptomatic lung disease resulting in shortness of breath at rest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether radiation therapy and two HER2-targeted drugs is a safe and effective treatment for HER2 positive breast cancer that has spread to the leptomeninges.

Who is the study for?

This trial is for individuals with HER2 positive breast cancer that has spread to the lining of the brain and spine. Participants must have a life expectancy over 8 weeks, normal organ function, and be able to undergo certain procedures like CSF sampling. Pregnant women or those with serious reactions to study drugs, significant lung disease, or recent major surgery cannot join.

What is being tested?

The study tests if radiation therapy followed by intrathecal (directly into the spinal canal) trastuzumab and pertuzumab improves survival in patients whose breast cancer has spread to their leptomeninges. It checks for safety and effectiveness of this treatment sequence.

What are the potential side effects?

Possible side effects include reactions related to infusion such as fever or chills, heart problems due to HER2 therapies affecting cardiac function, risk of infection from lowered blood counts, liver or kidney issues from drug toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recovered from surgery within the last 14 days and my surgeon has cleared me.

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I am willing and able to have a device implanted in my brain for treatment.

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I can care for myself but may need occasional assistance.

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My cancer, which has spread to the lining of my brain and spinal cord, is HER2 positive.

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I have brain metastases.

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My heart's pumping ability is normal.

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My cerebral spinal fluid has HER2 positive cells.

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I need a CSF test to confirm my brain or spinal cancer if an MRI hasn't.

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My cancer is HER2 positive, confirmed by specific tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience shortness of breath even when I am resting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Maximum Tolerated Dose (MTD) of Intrathecal (IT) pertuzumab in combination with IT trastuzumab

Phase 2: Overall Survival (OS)

Secondary study objectives

Progression Free Survival (PFS)

Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Radiation Therapy followed by 80 mg Pertuzumab and 80 mg TrastuzumabExperimental Treatment3 Interventions

Treatment will be initiated with radiation therapy (RT), either whole brain radiation therapy or focal brain/spine radiation therapy. Participants will be treated at dose level 4 of 4 with 80 mg pertuzumab along with 80 mg trastuzumab via Ommaya reservoir over 2-5 minutes. Pertuzumab and trastuzumab will be administered sequentially. Participants will be observed 30 to 60 minutes before commencing the next agent. Participants will be treated twice a week for 4 weeks, once a week for 4 weeks, and then once every 2 weeks.

Group II: Radiation Therapy followed by 40 mg Pertuzumab and 80 mg TrastuzumabExperimental Treatment3 Interventions

Treatment will be initiated with radiation therapy (RT), either whole brain radiation therapy or focal brain/spine radiation therapy. Participants will be treated at dose level 3 of 4 with 40 mg pertuzumab along with 80 mg trastuzumab via Ommaya reservoir over 2-5 minutes. Pertuzumab and trastuzumab will be administered sequentially. Participants will be observed 30 to 60 minutes before commencing the next agent. Participants will be treated twice a week for 4 weeks, once a week for 4 weeks, and then once every 2 weeks.

Group III: Radiation Therapy followed by 20 mg Pertuzumab and 80 mg TrastuzumabExperimental Treatment3 Interventions

Treatment will be initiated with radiation therapy (RT), either whole brain radiation therapy or focal brain/spine radiation therapy. Participants will be treated at dose level 2 of 4 with 20 mg pertuzumab along with 80 mg trastuzumab via Ommaya reservoir over 2-5 minutes. Pertuzumab and trastuzumab will be administered sequentially. Participants will be observed 30 to 60 minutes before commencing the next agent. Participants will be treated twice a week for 4 weeks, once a week for 4 weeks, and then once every 2 weeks.

Group IV: Radiation Therapy followed by 10 mg Pertuzumab and 80 mg TrastuzumabExperimental Treatment3 Interventions

Treatment will be initiated with radiation therapy (RT), either whole brain radiation therapy or focal brain/spine radiation therapy. Participants will be treated at dose level 1 of 4 with 10 mg pertuzumab along with 80 mg trastuzumab via Ommaya reservoir over 2-5 minutes. Pertuzumab and trastuzumab will be administered sequentially. Participants will be observed 30 to 60 minutes before commencing the next agent. Participants will be treated twice a week for 4 weeks, once a week for 4 weeks, and then once every 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Pertuzumab

2014

Completed Phase 3

~7500