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


Phase 2
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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.


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)

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Progression-Free Survival (PFS)

Outcome Description:

36 Months follow up for all patients

Outcome Time Frame:

Study assessment at 9 Months

Safety Issue:

No

Principal Investigator

Eric A. Strom, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0319

NCT ID:

NCT00929214

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Metastasized
  • Limited bone-only metastasis
  • Local Therapy
  • Radiation
  • Radiation Therapy
  • RT
  • Surgery
  • Standard Therapy
  • Chemotherapy
  • Endocrine Therapy
  • Aggression
  • Breast Neoplasms
  • Neoplasm Metastasis

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030