Trial studying safety and effects for Triple Negative Breast Cancer
Official title Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease
ClinicalTrials.gov ID: NCT03808337
What this study is testing
- What it's testing
- This study is testing whether adding stereotactic body radiotherapy (SBRT) to standard treatment can delay disease getting worse.
- Who it's for
- You may be able to join if you have triple negative breast cancer, metastatic breast cancer, or non‑small cell lung cancer that has spread and you have 1 to 5 metastases.
- What's involved
- You would receive SBRT, a precise radiation treatment, aimed at all tumor spots, together with your usual care. You will attend treatment visits and later check‑ins.
- Time commitment
- The study continues until the disease gets worse, with several treatment visits over a few weeks and later follow‑up visits.
- Phase 2: a mid-size study of how well it works
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
You may be able to join if
- Metastatic disease detected on imaging and histologically confirmed
- Metastatic breast cancer (all subtypes)
- Non-small cell lung cancer (NSCLC) without known targetable molecular alterations in EGFR, ALK, or ROS1
- NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations who had a history of disease progression on first-line tyrosine kinase inhibitor
- Patient can either have newly diagnosed metastatic disease, or have non-progressive disease on systemic therapy (for at least 3 months on systemic...
You likely can't join if
- Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator.
- Pregnant or lactating women.
- Other active malignancy within the last year, even if without evidence of disease.
- Clinical or radiological evidence of spinal cord compression
- Malignant pleural effusion or ascites.
- Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
See the full eligibility criteria
- Metastatic disease detected on imaging and histologically confirmed
- Metastatic breast cancer (all subtypes)
- Non-small cell lung cancer (NSCLC) without known targetable molecular alterations in EGFR, ALK, or ROS1
- NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations who had a history of disease progression on first-line tyrosine kinase inhibitor
- Patient can either have newly diagnosed metastatic disease, or have non-progressive disease on systemic therapy (for at least 3 months on systemic imaging)
- Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5 or fewer discrete disease sites that are technically amendable to SBRT (with the exception that if the primary disease is not...
- Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease...
- Disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine
- If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and treatment radiology-guided ablation, patients would be able to undergo...
- For de novo stage IV patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy.
- If primary disease was previously treated with local therapy in the form of surgery or radiation, any new local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation.
- Patients may receive palliative radiotherapy for symptomatic metastases or primary disease prior to enrollment provided that there is at least one other non-irradiated lesion amenable to SBRT at the time of enrollment.
- Patients with brain metastases are eligible if these lesions have been treated prior to enrollment.
- ECOG Performance status 0 - 2.
- Age \>/= 18 years.
- Able to provide informed consent.
- Female people must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 60 years old or no menses for 1\> year without an alternative medical cause
- Adequate baseline organ function to allow SBRT to all relevant targets, as determined by the treating radiation oncologist based on lesion location, lesion size, and proximity to relevant organs at risk.
- Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator.
- Pregnant or lactating women.
- Other active malignancy within the last year, even if without evidence of disease.
- Clinical or radiological evidence of spinal cord compression
- Malignant pleural effusion or ascites.
- Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
The study team makes the final eligibility decision.
Where it is enrolling
- Hartford, Connecticut, United States
- Norwalk, Connecticut, United States
- Miami, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Allentown, Pennsylvania, 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, but 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hartford, Connecticut, United States; Norwalk, Connecticut, United States; Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.