Participants with oligometastatic breast cancer for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, NY
Breast Cancer+7 More
Stereotactic body radiotherapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.

Eligible Conditions

  • HER2/Neu-positive Breast Cancer
  • Breast Cancer
  • ER+ Breast Cancer
  • Oligometastatic Breast Carcinoma
  • Metastatic Breast Cancer
  • Metastatic Breast Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 months from start of SBRT delivery

Month 3
Progression free survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Benign Tumors
100%Fatigue
100%Mucositis
100%Alopecia
100%Dizziness
100%Cranial Nerve Neuropathy
0%Hoarseness
0%Musculoskeletal Pain
0%Esophagitis
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT01344356) in the Benign Tumors ARM group. Side effects include: Fatigue with 100%, Mucositis with 100%, Alopecia with 100%, Dizziness with 100%, Cranial Nerve Neuropathy with 100%.

Trial Design

1 Treatment Group

Participants with oligometastatic breast cancer
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Participants with oligometastatic breast cancer · No Placebo Group · Phase 2

Participants with oligometastatic breast cancer
Radiation
Experimental Group · 1 Intervention: Stereotactic body radiotherapy · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiotherapy
2014
Completed Phase 4
~120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months from start of sbrt delivery
Closest Location: Memorial Sloan Kettering Commack (Limited Protocol Activities) · Commack, NY
N/AFirst Recorded Clinical Trial
5 TrialsResearching Breast Cancer
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have HER2+, regardless of ER status.
You have had at least 6 months of treatment with systemic therapy.
Isolated site of disease progression on FDG PET scan.
You are willing to undergo 12-245 treatments.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.