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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Phase 2: Overall Survival (OS)

Secondary outcome measures

Progression Free Survival (PFS)

Response Rate

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

Trastuzumab

2014

Completed Phase 4

~5190

Radiation Therapy

2017

Completed Phase 3

~7250

Pertuzumab

2014

Completed Phase 3

~7500

0 / 9Eligibility criteria met

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Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,456 Total Patients Enrolled

41 Trials studying Breast Cancer

5,780 Patients Enrolled for Breast Cancer

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,119 Total Patients Enrolled

97 Trials studying Breast Cancer

23,218 Patients Enrolled for Breast Cancer

Kamran Ahmed, MDPrincipal InvestigatorMoffitt Cancer Center

3 Previous Clinical Trials

131 Total Patients Enrolled

1 Trials studying Breast Cancer

31 Patients Enrolled for Breast Cancer

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04588545 — Phase 1 & 2

Breast Cancer Research Study Groups: Radiation Therapy followed by 10 mg Pertuzumab and 80 mg Trastuzumab, Radiation Therapy followed by 20 mg Pertuzumab and 80 mg Trastuzumab, Radiation Therapy followed by 40 mg Pertuzumab and 80 mg Trastuzumab, Radiation Therapy followed by 80 mg Pertuzumab and 80 mg Trastuzumab

Breast Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04588545 — Phase 1 & 2

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04588545 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this trial for potential participants?

"Affirmative. Per the clinicaltrials.gov record, this experiment is actively enrolling participants since its initial post on December 10th 2020. Currently, 39 patients are being sought from 2 medical centres for inclusion in this study."

Answered by AI

In what types of medical conditions is Radiation Therapy typically prescribed?

"Radiation Therapy is a viable solution for patients suffering from breast cancer, those at high risk of relapse, and others in need of first-line treatment."

Answered by AI

What is the magnitude of participation in this experiment?

"Indeed, according to clinicaltrials.gov the trial is actively enrolling patients and has been since December 10th 2020. The last update was on October 11th 2022 and 39 participants are being recruited across 2 sites."

Answered by AI

Have any past experiments employed Radiation Therapy?

"The initial research into radiation therapy was conducted in 1999 at Ospedale di Circolo e Fondazione Macchi. In the two decades since, 481 trials have been concluded with an additional 195 ongoing studies taking place primarily out of Tampa, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease

2020. "Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04588545.

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