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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06055881
• Collaborator: (none)
• Enrollment: 45
• Locations: 3
• Anticipated Duration (Months): 25
• Patients Per Site: 15
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma	Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVE:

1. To assess whether radiotherapy can provide clinically significant freedom from a change in systemic therapy (defined as for at least 6 months) for well-selected patients with oligoprogressive metastatic breast cancer.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and complete questionnaires on study.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 30, 2025
• Anticipated Study Completion Date: Oct 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Observational Patients undergo blood sample collection and complete questionnaires on study.	Other: Non-Interventional Study; Non-interventional study

Outcome Measures

Primary Outcome Measures

1. Freedom from a change in systemic therapy [At 6 months]

   Freedom from a change in systemic therapy defined as no change in systemic therapy at 6 months after radiotherapy and patient survival at 6 months after radiotherapy. Treatment failure would indicate that there is no longer stability of systemic therapy (and thereby requires a change in systemic therapy to a different agent).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

• 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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Kimberly S. Corbin, M.D., Mayo Clinic in Rochester

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT06055881
• Other Study ID Numbers: GMROR2232; NCI-2023-03208; 22-002943; GMROR2232
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 28, 2023