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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055881
• Other study ID #: GMROR2232
• Secondary ID: NCI-2023-0320822
• Status: Recruiting
• Start date: October 23, 2023
• Est. completion date: October 30, 2025

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

I. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from a change in systemic therapy	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).	At 6 months

External Links

•   Mayo Clinic Clinical Trials