Aggressive Local Therapy for Limited Bone-only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients
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.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Progression-Free Survival (PFS)
36 Months follow up for all patients
Study assessment at 9 Months
No
Eric A. Strom, MD, BS
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2008-0319
NCT00929214
June 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |