Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00929214|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2009
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Standard Therapy Procedure: Local Therapy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients|
|Actual Study Start Date :||June 2009|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|