Primary Breast Oligoprogressive Metastatic Disease Treated with Stereotactic Body Radiation Therapy to Obviate the Need to Change Systemic Therapy (BOSS)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-002943
- Scottsdale/Phoenix, Arizona: 22-002943
NCT ID: NCT06055881
Sponsor Protocol Number: GMROR2232
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.
- 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.
- 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 fourthline), 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). Patients with ER negative, PR positive, and HER2 negative disease will also be excluded.
- 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 CNSdirected 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 8/15/23. 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 |
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 |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available