Can zapping bone tumors keep breast cancer at bay?
NCT ID NCT00929214
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether adding local treatments like surgery or high-dose radiation to standard chemotherapy or hormone therapy can help breast cancer patients whose disease has spread to 1–3 bones. The goal is to see if this combination keeps the cancer from progressing longer than standard therapy alone. The study enrolled 35 participants and is no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Standard therapy (chemotherapy and/or endocrine therapy) plus local therapy (radiation and/or surgery)
- What this could lead to
- If it works, this could show that aggressively treating a few bone spots helps keep breast cancer from spreading further, potentially improving how long the disease stays controlled.
- What could go wrong
- This is a small, early-phase trial with only 35 participants, so results may not apply to everyone. Adding local therapy also carries risks like side effects from radiation or surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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35 people
The number who actually took part.
- Started
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Jun 2009
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Breast cancer with metastasis to skeletal sites only 2. 1 to 3 bone metastatic sites (metastatic lesions in the same bone that are within 3 cm of each other are considered as one site) 3. KPS greater than or equals to 70 4. Absolute neutrophil count of \> 1500 per microliter and platelet count \> 100,000 per microliter; AST and alkaline phosphatase \< = 2.5 X normal limits, bilirubin \< = 1.5 x normal limits, calculated creatinine clearance \> 50 ml/min using Cockcroft-Gault formula: CrCl male = (140-age) x (wt. in kg)/(Serum Cr x 72); CrCl female = 0.85 x (CrCl male) 5. Patients may or may not have started bis-phosphonates. 6. Patients who have received prior chemotherapy for their original breast cancer treatment are still eligible. 7. Previous use of systemic therapy for bone metastasis is allowable as long as the systemic therapy use fits within the treatment plan as described in Proposed Treatment/Study Plan. (If the patient received less than 3 - 9 months of systemic therapy previously, the use of additional systemic therapy may be necessary to fit within the treatment plan) 8. Treating physician assesses tumor to be sufficiently distant from sensitive structures to be able to achieve greater than or equal to 66 Gy. (i.e., spinal cord tolerance respected in vertebral body metastasis. 9. Patients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy. Otherwise systemic therapy should be given first as outlined in abstract treatment study plan sections 1 and 2. Exclusion Criteria: 1. Distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone 2. Prior radiation to site(s) of distant metastasis of bone 3. History of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment 4. Second primary malignancy (skin cancer other than melanoma allowed) that is disease free for less than 3 years 5. Premenopausal and postmenopausal (amenorrheic for less than 12 months) women with either a positive or no pregnancy test (serum or urine) at baseline within 7 days study enrollment. Postmenopausal women who are amenorrheic for more than 12 months do not require pregnancy test. 6. Women with child-bearing potential not using a reliable an appropriate contraceptive method. 7. Patients with child-bearing potential will agree to use contraception while on study and for 30 days from the date of the last therapy on protocol. 8. If the patient requires surgery of the bone metastasis, clinically serious comorbidities that render patient not medically fit for surgery (e.g. congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias and chronic lung disease not well controlled with medication; myocardial infarction within 12 months of enrollment) 9. Central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant to preclude informed consent or interfere with complying with protocol treatments.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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