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Primary Breast Oligoprogressive Metastatic Disease Treated With Stereotactic Body Radiation Therapy To Obviate The Need To Change Systemic Therapy (BOSS)

Overview

About this study

The purpose of this study is to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response, to assess the role of circulating tumor DNA (ctDNA) in stratifying outcomes (and corresponding treatment paradigms) for patients with oligoprogressive breast cancer, and to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response.  The future aim of this work is to develop a large, cooperative group trial testing the role of local therapy for oligoprogressive breast cancer patients.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Able to provide written consent.
  • Patient has given permission to give tumor/blood sample for research testing.
  • Patients with metastatic breast cancer and at least 12 months of clinical response to systemic therapy, with the subsequent development of 1-3 extracranial sites of oligoprogressive disease.

Exclusion Criteria:

  • Active second primary malignancy.
  • Pregnant or nursing women, or men or women of childbearing potential who are unwilling to employ adequate contraception.
  • ECOG Performance Status > 2.
  • > 3 extracranial sites of oligoprogressive disease.
  • Intracranial metastatic disease.
  • 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 that in the opinion of the treating physician is not safe to deliver.
  • Inability on the part of the patient to understand the informed consent to be compliant with the protocol.
  • Patient refusal to follow up at Mayo Clinic Radiation Oncology.
  • Greater than 10 fractions of prescribed radiotherapy.
  • Less than or equal to 3 Gy per fraction prescribed dose.
  • Treatment with 8 Gy in 1 fraction or 20 Gy in 5 fractions.
  • Patients with triple negative disease (negative for ER, PR, and HER2).

Eligibility last updated 3/17/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Roman Kowalchuk, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sarah James, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

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CLS-20555625

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