Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title: Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients

Status Active, not recruiting

Clinical Trial Summary

The goal of this clinical research study is to find out if adding local therapy (surgery and/or radiation) to standard therapy (chemotherapy or endocrine therapy) in the treatment of patients with metastatic breast cancer can help to control the disease for a longer period of time than standard therapy alone.

Clinical Trial Description

Study Treatments:

Current standard of care for breast cancer patients whose disease has spread to the bones is to treat them with chemotherapy or endocrine therapy. However, using radiation and surgery as well may help to get rid of the cancer cells in the bone lesions.

All participants will receive separate consent documents to sign that will explain the routine surgery, radiation therapy, and chemotherapy.

Standard Therapy:

If the imaging scans show that you are not at increased risk for bone fracture, you will receive 3 to 9 months of systemic therapy that is most appropriate for you as decided by your doctor. You may also be placed on endocrine therapy as decided by your doctor. If you have received drugs in the past that could cause heart-related side effects and/or a history of heart disease, you may have heart function tests, if your cancer doctor decides it is needed.

Study Visits:

After you have received 3-9 months of standard therapy, you will receive an MRI scan, a PET/CT scan, an X-ray, and a whole-body bone scan to make sure you still have no more than 3 bone metastases. Blood (about 2 tablespoons) and urine tests will also be collected to make sure you have no more than 3 bone metastases.

Local Therapy:

If you still have no more than 3 bone metastases, local treatments including high-dose radiation therapy and/or surgery will be given. The most appropriate local therapy will be chosen by your treating radiation oncologist, surgeon, and medical oncologist.

For bones with fractures or at risk for fracture, a rod or other devices may be placed in the bone to fix the bone. Radiation therapy involves daily treatments during weekdays that may last 5 to 7 weeks in a row. Each daily treatment may last 30 - 40 minutes. For special cases, shorter courses of radiation therapy may be offered to treat the lesions in the spine. Radiation types, such as photon, electron, or proton will be selected by your doctor.

If you have a risk of bone fracture due to the cancer, you may be treated with surgery and/or radiation first, before starting standard therapy. Again, the most appropriate local therapy will be chosen by your treating radiation oncologist, surgeon, and medical oncologist.

After completing the local therapies, you will receive an MRI scan, a PET/CT scan, a X-ray, and a whole-body bone scan to make sure you still have no more than 3 bone metastases. Blood (about 2 tablespoons) and urine will also be collected to make sure you have no more than 3 bone metastases. Then, you will receive 3 to 9 months of systemic therapy that is most appropriate for you as decided by your doctor. You may also be placed on endocrine therapy as decided by your doctor.

Length of Study:

The standard systemic therapy treatments may last 3 to 9 months. The radiation therapy process may last 6 to 8 weeks. Surgery, including recovery, may last 4 to 6 weeks. You will be taken off study early if you are found to have more than 3 lesions, if the disease worsens, or if you have intolerable side effects.

Long-Term Follow-up:

After the local and standard therapies are finished, you will have a follow-up visit at 3 months and every 3 months for the 1st year after the therapies, and then every 6 months for the 2nd and 3rd year after the therapies. At each of these visits, the following tests will be performed:

• You will have periodic tests which may include an MRI scan, a PET/CT scan, an X-ray, and a whole-body bone scan to check on the status of the disease. Your doctor will decide which tests you will need. The tests will be done every 3 months for the first year and then every 6 months for the next 2 years.

• Blood (about 2 tablespoons) and urine will be collected to check on the status of the disease.

• You will complete QOL questionnaires.

After the completion of the 36 month visit, you are encouraged to follow-up at any time after the last visit up to 1 year. Your doctor may request that you have an MRI scan, a PET/CT scan, an X-ray, and/or a whole-body bone scan to check on the status of the disease.

This is an investigational study. The use of local treatments (surgery and radiation therapy) to treat metastatic lesions of the bone is investigational. The use of chemotherapy and endocrine therapy is standard of care for breast cancer patients with metastases.

Up to 75 evaluable patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

• NCT number: NCT00929214
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 24, 2009
• Completion date: December 1, 2024