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New treatment option for Breast Carcinoma
Official title Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy
ClinicalTrials.gov ID: NCT06055881
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
- More than 3 extracranial sites of oligoprogressive disease
See the full eligibility 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...
- 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...
- Eastern Cooperative Oncology Group (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.
- 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
- More than 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.