Study on Aggressive Local Therapy for Bone-Only Metastasis to Improve Outcomes in Breast Cancer Patients
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT00929214
This clinical trial is exploring whether adding local treatments like surgery and radiation to standard therapies can help control breast cancer that has spread to the bones more effectively than standard treatments alone.
Patient Parameters
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Program Overview
The aim of this study is to see if combining local treatments, such as surgery and radiation, with standard therapies like chemotherapy or hormone therapy can better manage breast cancer that has spread to the bones. Researchers want to find out if this approach can help keep the disease under control for a longer time compared to using standard treatments alone.
Description
In this study, all participants will receive standard treatments, which may include chemotherapy or hormone therapy, depending on what their doctor thinks is best. If imaging tests show that you are not at high risk for bone fractures, you will receive 3 to 9 months of these standard treatments. If you have a history of heart disease or have taken certain medications before, you might need heart tests as well.
After 3 to 9 months of standard treatment, you will have several scans and tests to check if you still have no more than 3 bone metastases. If so, you may receive local treatments like high-dose radiation or surgery, chosen by your medical team. Radiation therapy could last 5 to 7 weeks, with daily sessions on weekdays. If there is a risk of bone fracture, you might receive surgery or radiation before starting standard therapy.
Once local treatments are completed, you will undergo more scans and tests to ensure you still have no more than 3 bone metastases. Then, you will continue with 3 to 9 months of standard therapy. The entire study treatment could last several months, and you will be monitored closely throughout.
After finishing all treatments, you will have follow-up visits every 3 months for the first year, and every 6 months for the next two years. During these visits, you will have scans and tests to check on the status of your disease and complete quality of life questionnaires.
This study is investigational, meaning the use of local treatments for bone metastases is still being researched. Up to 75 patients will participate, all at MD Anderson.
Eligibility Criteria
Inclusion Criteria
- Have breast cancer that has spread only to the bones.
- Have 1 to 3 bone metastases (close lesions in the same bone count as one site).
- Be in good general health with a performance status score of 70 or higher.
- Have adequate blood counts and organ function based on specific lab tests.
- May or may not have started bisphosphonates.
- Previous chemotherapy for breast cancer is allowed.
- Previous systemic therapy for bone metastasis is allowed if it fits the study plan.
- Tumor must be far enough from sensitive areas to allow safe radiation treatment.
- If at risk of bone fracture, may receive local therapy before systemic therapy.
Exclusion Criteria
- Cancer has spread to organs other than bones.
- Previous radiation to bone metastasis sites.
- History of certain autoimmune diseases that increase radiation risk.
- Another cancer within the last 3 years, except for certain skin cancers.
- Women who are pregnant or not using effective birth control.
- Serious health conditions that make surgery unsafe.
- Significant mental health issues that affect understanding or following the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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