Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in… (NCT00929214) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients
United States35 participantsStarted 2009-06-24
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on using aggressive local therapy for breast cancer that has spread only to bones — does my specific situation, including how many bone metastases I have and whether the cancer is truly limited to bone, actually match what this study is targeting?
2Since this is a Phase 2 trial, the main goal is still gathering early evidence on whether this approach works and is safe — what does my doctor think is currently known and unknown about the risks of aggressive local treatment to bone metastases compared to standard systemic therapy alone?
3The trial is no longer enrolling new patients — does that mean results might be available soon, and could my doctor look into any published or preliminary findings that might help us decide if this approach is worth pursuing through other means?
4Progression-free survival is what this trial is measuring — can my doctor explain what that means in practical terms for me, and how does delaying progression in bone-only metastatic breast cancer translate to quality of life or overall survival?
5Would my doctor recommend I consider standard systemic treatments first, or are there reasons why aggressively targeting the bone metastases locally might be worth discussing as part of my treatment plan right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients with Progression-Free Survival (PFS)
. 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.
Exclusion criteria
. 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.
. 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)