Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01242800|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2010
Last Update Posted : December 22, 2021
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||Not Applicable|
- 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|
|Actual Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||June 30, 2022|
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 [ Time Frame: Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years ]Overall survival, defined as time from randomization to death from any cause. All patients will be followed for survival through 5 years. Cases with incomplete follow-up or without record of vital status will be censored at the date of last contact.
- Uncontrolled chest wall disease [ Time Frame: Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years ]The chest wall/breast will be called "controlled" if there is no clinical or radiological evidence of the local tumor; or if there is evidence of the primary tumor but no skin nodules, ulceration, or chest wall fixation. Time to uncontrolled chest wall disease is defined as time from randomization to the development of uncontrolled chest wall disease. Patients with controlled chest wall will be censored at the last date of evaluation.
- Health-related quality of life [ Time Frame: Assessed at baseline, randomization, 6, 18 and 30 months after randomization ]The FACT-Breast Trial Outcome Index will be used as the primary HRQL endpoint. FACT-B TOI scores at baseline, randomization, 6, 18 and 30 months after randomization will be calculated and compared for participants randomized to early local therapy versus palliative local therapy. The change of FACT-B TOI scores over time will be compared between treatment arms as well. For the palliative local therapy arm, the change of QOL from randomization to the time of decision for local therapy will also be measured.
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
|Principal Investigator:||Seema A. Khan, MD||Robert H. Lurie Cancer Center|