Radiation Therapy for Breast Cancer Bone Metastases
Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer
Recruiting
Phase 1Phase 2Interventional Study
Bone MetastasesBreast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
This trial is looking for patients with breast cancer that has spread to the bones. Participants will receive a type of radiation treatment that is highly focused on the tumors while aiming to reduce damage to healthy tissue.
Are You a Good Fit for This Trial?
Must not be takingBisphosphonatesEndocrine therapyTargeted therapy
You may be able to join if
I have been diagnosed with invasive breast cancer
I have bone metastases confirmed by MRI
I am able to give my consent to join the study
My tumor is at least 2 mm away from my spinal cord
I can have a maximum of three separate spinal metastases
I have enough good health to participate according to tests
I have had previous treatments that did not work
I can have my previous chemotherapy side effects recover
You may not be able to join if
I have a weak or unstable spine
I have serious heart or kidney diseases
I cannot lie flat for at least 30 minutes for an MRI
I had previous radiation therapy to my spine in the last 3 months
I received chemotherapy in the last 2 weeks
I have a pacemaker
I am pregnant
I am unable to attend regular follow-ups
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of invasive breast cancer
2. Signed informed consent
3. Bone metastases (confirmed by MRI within 4 weeks of enrollment).
4. Paraosseous soft tissue ≤ 5cm. The tumour could involve the vertebral column, but did not have to, nor did it need to enter the spinal canal.
…
Inclusion Criteria:
1. Diagnosis of invasive breast cancer
2. Signed informed consent
3. Bone metastases (confirmed by MRI within 4 weeks of enrollment).
4. Paraosseous soft tissue ≤ 5cm. The tumour could involve the vertebral column, but did not have to, nor did it need to enter the spinal canal.
5. KPS ≥ 40 or ECOG 0-2.
6. The tumor is at least 2 mm away from the spinal cord. If the tumor is closer than 2 mm, surgical resection is required prior to FSRT or the total prescription dose of spinal cord is strictly limited.
7. Failure of previous conventional external beam radiotherapy or surgery, residual tumor after surgery, medical inoperability, and refusal to undergo surgery.
8. A maximum of three distinct noncontiguous spinal metastases per patient was allowed, and each of the separate sites may have involvement of 2 contiguous vertebral bodies.
9. Patients have sufficient bone marrow reserve and liver and kidney function: neutrophil count ≥ 1500 cells / mm3; platelet count ≥ 70000 / mm3; hemoglobin (Hgb) ≥ 8.0 g / dl; if there is liver metastasis, AST and ALT \< 3x ULN
10. The interval between systemic chemotherapy is more than 2 weeks, and the side effects recovery from previous treatment ≤ grade 1
11. Patients receiving bisphosphonates, endocrine or targeted therapy at the same time were not included
Exclusion Criteria:
1. Patients with mechanically unstable spine or epidural spinal cord compression were excluded; however, patients with previously documented spinal cord compression that had been decompressed and stabilized were eligible. Patients with \> 50% loss of vertebral body height were excluded.
2. Patients in whom a delay in initiating treatment might have adversely affected neurological outcome.
3. Patients with a pacemaker, unable to undergo MR imaging and unable to lie flat for at least 30 minutes.
4. Patients who had a history of previous radiotherapy to the spine at the current level of interest.
5. Patients who had received prior external-beam irradiation to the spine within 3 months of registration.
6. Patients who had received systemic radiotherapy (Strontium-89) within 30 days of starting protocol treatment.
7. Patients who had received chemotherapy within 2 weeks of starting protocol treatment.
8. Patients who are unwilling or unable to receive regular follow-up.
9. The patients judged by the researchers who could not be included in some special cases.
10. Serious complications: cardiovascular disease, end-stage renal disease, serious liver disease, infection, et al.
11. Pregnant women.
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