RightFit
RecruitingPhase 2

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

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests adding precisely targeted radiation (SBRT) to usual drug treatment for breast cancer that has spread to a few places. It is for people whose cancer has worsened in just one place. The study will see if treating that spot while keeping the same drugs can help stop cancer from getting worse elsewhere or spreading.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Willing and able to give informed consent, meaning you agree after learning about the study.
  • Breast cancer that has spread, confirmed by a tissue sample. It must be ER-positive/HER2-negative (over 5% ER staining) or HER2-positive, including low or high HER2 levels. ER and HER2 are markers tested in cancer cells.
  • Cancer stayed stable or fully responded to drug treatment for at least 6 months, without getting worse.
  • An FDG PET scan shows cancer getting worse in only one place.
  • Have given consent for study 12-245.
  • Fully active or able to walk and do light work, with limits only on hard physical activity (ECOG score 0–1).

Who can't join

  • Pregnant.
  • A serious health problem that makes radiation unsafe, including disorders of the body's supporting tissues.
  • Cancer inside the skull, now or in the past.
  • Past radiation to the planned treatment spot that prevents a new radiation plan from safely protecting healthy tissue.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 or older * Willing and able to provide informed consent * Metastatic breast cancer, biopsy proven * ER+/HER2-, defined as \>5% ER+ staining * HER2+ (regardless of ER status), including HER2-low and high expressors * History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression) * Isolated site of disease progression on FDG PET scan * Consented to 12-245 * ECOG performance status 0-1 Exclusion Criteria: * 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.

Study sites (8)

NJ

NY

PA