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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Willing and able to provide informed consent

Metastatic breast cancer, biopsy proven

ER+/HER2-, defined as >5% ER+ staining

Disqualifiers

Pregnancy

Serious medical comorbidity precluding radiation, including connective tissue disorders

Intracranial disease (including previous intracranial involvement)

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic body radiotherapy

    Radiation

    SBRT will be initiated as soon as possible, at not beyond 8 weeks of baseline measurements. Recommended dosing is per department standards for oligometastatic disease (ie, 10 Gy x 3 or 7-8 Gy x 5 fractions daily, excluding weekends and departmental holidays)

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Participants with oligometastatic breast cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.

Time frame
3 months from start of SBRT delivery

Secondary outcomes

Other outcomes

Sponsors and contacts

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