Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05534438

Stereotactic Body Radiation Therapy to Extend Systemic Therapy Benefit in Patients With Solitary Breast Cancer Progression

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16

46

Participants Needed

8

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether using Stereotactic Body Radiation Therapy (SBRT) to treat a single metastatic site where breast cancer has worsened may be an effective approach for people with oligometastatic breast cancer. Participants will continue their usual drug therapy while receiving SBRT. This combination is being studied to see if it can prevent the cancer from worsening at other sites or spreading further. Participants with oligometastatic breast cancer who have isolated progression after at least 6 months of response to systemic therapy will receive image-guided SBRT targeted at the progressive lesion seen on imaging. SBRT dosing follows standard department protocols for oligometastatic disease, typically 10 Gy for 3 fractions or 7-8 Gy for 5 daily fractions excluding weekends and holidays. Systemic therapy will be paused during radiation days and resumed afterward. During the study, participants will be monitored for progression-free survival starting from the beginning of SBRT treatment, with assessments at 3 months. Researchers will evaluate the effect of adding SBRT to ongoing drug therapy on cancer progression. Participants will undergo regular imaging and clinical evaluation while continuing their usual care. The total duration of participation varies based on individual treatment schedules and follow-up assessments.

CONDITIONS

Brief Title

A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Willing and able to provide informed consent
  • Biopsy-proven metastatic breast cancer
  • ER+/HER2- with more than 5% ER+ staining, or HER2+ including low and high expressors
  • History of at least 6 months sustained response to systemic therapy without progression
  • Isolated site of disease progression on FDG PET scan
  • ECOG performance status 0 or 1
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Serious medical conditions that prevent radiation, including connective tissue disorders
  • Intracranial disease, including previous brain involvement
  • Previous radiotherapy to the treatment site that prevents safe radiation planning

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 8 weeks from baseline measurements

Participants receive stereotactic body radiotherapy (SBRT) to the progressive lesion while maintaining their existing systemic therapy, which is paused during radiation days and resumed after completion.

Daily visits for 3 to 5 radiation sessions excluding weekends and holidays

Follow-up

Duration - At least 3 months from start of SBRT delivery

Participants are monitored for progression-free survival starting from the start of SBRT delivery.

Periodic visits as per clinical follow-up

Trial Site Locations

Total: 8 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 10065

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

8

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, United States, 18103

Not Yet Recruiting

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Research Team

A

Amy Xu, MD, PhD

A

Atif Khan, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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