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Targeted Radiation + Drug Therapy for Breast Cancer

Phase 2

Recruiting

Led By Amy Xu, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Metastatic breast cancer, biopsy proven

ECOG performance status 0-1

Must not have

Serious medical comorbidity precluding radiation, including connective tissue disorders

Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months from start of sbrt delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding SBRT to the usual cancer drug therapy can help people with oligometastatic breast cancer by preventing the cancer from worsening in other metastatic sites or spreading.

Who is the study for?

This trial is for adults with metastatic breast cancer who've had a good response to drug therapy for at least 6 months. It's open to those with certain hormone receptor statuses, able to consent, and have only one site of disease progression visible on a scan. Pregnant individuals, those with previous radiation at the target site or brain involvement, and serious medical conditions that conflict with radiation are excluded.

What is being tested?

The study tests adding Stereotactic Body Radiation Therapy (SBRT) targeting just one metastatic site alongside ongoing usual drug therapy in people with oligometastatic breast cancer. The goal is to see if this precise radiation can prevent the cancer from getting worse elsewhere.

What are the potential side effects?

Potential side effects of SBRT may include skin reactions, fatigue, pain at the treatment site, and rarely more severe issues like damage to nearby organs or tissues depending on where the treatment is aimed.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer has spread, confirmed by a biopsy.

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I am fully active or can carry out light work.

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My cancer is mainly driven by estrogen receptors.

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My cancer is HER2 positive, no matter the ER status.

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I am 18 years old or older.

Exclusion Criteria

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

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I have a serious health condition that prevents me from receiving radiation therapy.

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I've had radiation before where they now want to treat, and can't have more without risking harm.

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I have or had a brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months from start of sbrt delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months from start of sbrt delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months from start of sbrt delivery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival

Side effects data

From 2018 Phase 4 trial • 19 Patients • NCT01344356

100%

Mucositis

100%

Fatigue

100%

Dizziness

100%

Cranial Nerve Neuropathy

100%

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Benign Tumors

Malignant Tumors

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with oligometastatic breast cancerExperimental Treatment1 Intervention

Participants with oligometastatic breast cancer with isolated progression after sustained (\>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic body radiotherapy

2021

Completed Phase 4

~840

0 / 8Eligibility criteria met