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Primary Breast Oligoprogressive Sites Treated with Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)

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Mayo Clinic

Status

Enrolling

Conditions

Anatomic Stage IV Breast Cancer AJCC V8
Metastatic Breast Cancer
Breast Carcinoma

Treatments

Other: Surveys
Procedure: Positron Emission Tomography
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Procedure: Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT06055881
NCI-2023-03208 (Registry Identifier)
22-002943 (Other Identifier)
GMROR2232 (Other Identifier)

Details and patient eligibility

About

This study assesses if metastasis-directed radiation therapy (Stereotactic body radiation therapy - SBRT) can delay a change in systemic therapy, and if circulating tumor cells in the bloodstream can help guide treatment options in metastatic breast cancer patients with progressive disease

Enrollment

45 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years.

  • Histological confirmation of primary breast cancer.

  • Patients with metastatic breast cancer and at least 12 months of clinical response to first-line systemic therapy, with the subsequent development of 1-3 extracranial sites of oligoprogressive disease, and who plan for the continuation of the current systemic therapy.

    • NOTE: patients with de novo metastatic disease and those developed metastatic disease after initially localized disease can both be included.

OR

  • Patients with metastatic breast cancer and at least 6 months of clinical response to second-line systemic therapy (or further, e.g., third- or fourth-line), with the subsequent development of 1-3 extracranial sites of oligoprogressive disease.
  • ECOG Performance Status (PS) ≤ 2.
  • Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willing to provide blood samples for correlative research purposes.
  • Receiving radiation therapy as specified in the protocol.

Exclusion criteria

  • Male patients.

  • Nursing or pregnant women.

  • Men or women of childbearing potential who are unwilling to employ adequate contraception.

  • Patients with triple negative disease (negative for ER, PR, and HER2).

  • Active second primary malignancy

  • > 3 extracranial sites of oligoprogressive disease

  • Active CNS disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.

    • Active connective tissue disease that is felt by the treatment team to pose an excess risk of toxicity.

    • Prior radiation that overlaps with the intended treatment volume such that, in the opinion of the patient's Radiation Oncologist, radiotherapy to progressing sites will not be safe.

      • NOTE: patients with some dose overlap with prior radiotherapy that is deemed safe by the patient's Radiation Oncologist can be included in the trial.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Metastatic Breast Cancer
Experimental group
Description:
Breast cancer patients with ER+/PR± (any PR status)/HER2- disease or HER2+ disease (any ER or PR status) will receive radiotherapy that consists primarily of Stereotactic body radiation therapy (SBRT), but at a minimum, it will consist of dose-escalated, moderately hypofractionated radiotherapy (as opposed to conventional fractionation or conventional palliative treatment regimens).
Treatment:
Procedure: Magnetic Resonance Imaging
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Procedure: Positron Emission Tomography
Procedure: Computed Tomography
Procedure: Biospecimen Collection
Other: Surveys

Trial contacts and locations

2

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Central trial contact

Clinical Trials Referral Office

Data sourced from clinicaltrials.gov

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