Breast CancerPhase 2NCT00929214
Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients
A Phase 2 study testing Standard Therapy and Local Therapy in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard Therapy and Local Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2009to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast cancer with metastasis to skeletal sites only
- 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)
- KPS greater than or equals to 70
- 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)
- Patients may or may not have started bis-phosphonates.
- Patients who have received prior chemotherapy for their original breast cancer treatment are still eligible.
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- 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)
- 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.
- 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.
Who cannot join
- Distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
- Prior radiation to site(s) of distant metastasis of bone
- History of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment
- Second primary malignancy (skin cancer other than melanoma allowed) that is disease free for less than 3 years
- 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.
- Women with child-bearing potential not using a reliable an appropriate contraceptive method.
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- 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.
- 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)
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- Standard Therapy, Local Therapy
- Keywords
- Breast Cancer, Metastasized, Limited bone-only metastasis, Local Therapy, Radiation, Radiation Therapy, RT, Surgery, Standard Therapy, Chemotherapy, Endocrine Therapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TherapyDrug
Also called Chemotherapy, Endocrine Therapy, Systemic Chemotherapy
Chemotherapy and/or Endocrine Therapy:
For 3 - 9 months, all patients will receive systemic chemotherapy agents appropriate for the tumor characteristics and patient's prior treatment history, and may also be placed on endocrine therapy as determined by the treating medical oncologist.
Local TherapyProcedure or surgery
Also called Radiation Therapy, RT, XRT, Surgery
Surgery and/or Radiation Therapy
With no more than 3 bone metastases, local treatments including high-dose radiation therapy and/or surgery will be given. 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. Surgery, including recovery, may last 4 to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy + Local Therapy | Experimental | Systemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation) Receives: Drug: Standard Therapy; Procedure: Local Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Progression-Free Survival (PFS)
Progression-free survival defined as 1) development of distant soft tissue or visceral metastasis at any time, 2) progression of bone lesion(s) that received planned local therapy (as defined by the imaging response criteria described by Hamaoka et al., and 3) development of new bone lesions after patient receives planned local therapy. Development of additional bone metastasis prior to receiving planned local therapy not be considered as event if the total number of bone metastasis is 3 or less. An event has occurred if additional bone metastasis develops and total number of bone metastasis is 4 or more.
Measured: Study assessment at 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study start24 Jun 2009
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric A. Strrom, MD, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929214
- Sponsor's protocol ID
- 2008-0319
- Other IDs
- NCI-2011-02165
- Status last verified
- Nov 2025
- First submitted
- 25 Jun 2009
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00929214
- Acronym / sponsor ID
- 2008-0319
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Metastasized, Limited bone-only metastasis, Local Therapy, Radiation, Radiation Therapy, RT, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Jun 2009 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy + Local Therapy | Experimental | Drug: Standard Therapy, Procedure: Local TherapySystemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Breast cancer with metastasis to skeletal sites only
- 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)
- KPS greater than or equals to 70
- 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)
- Patients may or may not have started bis-phosphonates.
Key exclusion criteria (9 listed)
- Distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
- Prior radiation to site(s) of distant metastasis of bone
- History of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment
- Second primary malignancy (skin cancer other than melanoma allowed) that is disease free for less than 3 years
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TherapyAlso: Chemotherapy, Endocrine Therapy, Systemic ChemotherapyChemotherapy and/or Endocrine Therapy: For 3 - 9 months, all patients will receive systemic chemotherapy agents appropriate for the tumor characteristics and patient's prior treatment history, and may also be placed on endocrine therapy as determined by the treating medical oncologist. | Drug | Standard Therapy + Local Therapy |
| Local TherapyAlso: Radiation Therapy, RT, XRT, SurgerySurgery and/or Radiation Therapy With no more than 3 bone metastases, local treatments including high-dose radiation therapy and/or surgery will be given. 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. Surgery, including recovery, may last 4 to 6 weeks. | Procedure or surgery | Standard Therapy + Local Therapy |
Primary outcome
Number of Patients with Progression-Free Survival (PFS)
Time frame: Study assessment at 9 Months
Progression-free survival defined as 1) development of distant soft tissue or visceral metastasis at any time, 2) progression of bone lesion(s) that received planned local therapy (as defined by the imaging response criteria described by Hamaoka et al., and 3) development of new bone lesions after patient receives planned local therapy. Development of additional bone metastasis prior to receiving planned local therapy not be considered as event if the total number of bone metastasis is 3 or less. An event has occurred if additional bone metastasis develops and total number of bone metastasis is 4 or more.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A. Strrom, MD, BS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Therapy and Local Therapy in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Progression-Free Survival (PFS) (time frame: Study assessment at 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.