Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
|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: NCT01242800|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2010
Last Update Posted : January 1, 2019
RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer.
PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: palliative surgery Procedure: therapeutic conventional surgery Radiation: palliative radiation therapy Radiation: radiation therapy||Phase 3|
- To evaluate whether early local therapy comprising surgery of intact primary disease compared to local palliative therapy only in patients with stage IV breast cancer, whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival.
- To compare the time to uncontrolled chest wall disease between patients treated with these regimens.
- To determine whether there is a difference in health-related quality-of-life (HRQOL) between patients treated with these regimens.
- To determine whether the absolute value of circulating tumor cells (CTC) burden at 6 months following randomization (time +6) will be lower in the palliative therapy arm than in early local therapy arm, and whether this value is inversely related to survival (lower CTC, longer survival).
- To collect tumor and blood specimens for future exploration of the biological interactions between the primary tumor and metastatic lesions and the effect of primary tumor resection.
OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor and treatment plan (ER+ or PR+, HER2-, endocrine therapy alone vs ER+ or PR+, and HER2-, chemotherapy and/or endocrine therapy vs ER- or PR-, and HER2- vs HER2+), and number of involved organ systems with distant disease (regional nodes in the axillary, supraclavicular, and internal mammary locations are not considered distant sites) (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.
- Arm II: Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.
Patients may undergo blood and tumor tissue sample collection for circulating tumor cells (CTC) burden and future studies.
Patients complete the Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT- TOI) and FACT - General (22) and the Breast Cancer Subscale (FACT-B) quality-of-life questionnaires at baseline and periodically during study.
After completion of study therapy, patients are followed up periodically for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||391 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer|
|Actual Study Start Date :||February 8, 2011|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2027|
Active Comparator: Arm I
Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.
Procedure: palliative surgery
Undergo standard palliative surgery
Radiation: palliative radiation therapy
Undergo standard palliative radiotherapy
Experimental: Arm II
Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.
Procedure: therapeutic conventional surgery
Undergo early surgery
Radiation: radiation therapy
- Overall survival
- Uncontrolled chest wall disease
- Health-related quality of life
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): NCT01242800
Show 411 Study Locations
|Principal Investigator:||Seema A. Khan, MD||Robert H. Lurie Cancer Center|