Aggressive Local Therapy for Limited Bone-only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Aggressive Local Therapy for Limited Bone-only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients|
- Number of Patients with Progression-Free Survival (PFS) [ Time Frame: Study assessment at 9 Months ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: Standard Therapy + Local Therapy
Systemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation)
Drug: Standard Therapy
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.
Other Names:Procedure: Local Therapy
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00929214
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric A. Strom, MD, BS||M.D. Anderson Cancer Center|