Clinical trial NCT06055881: Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy
Official title: Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from a change in systemic therapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Roman O. Kowalchuk, MD
role: PRINCIPAL_INVESTIGATOR
References: