Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

Official Title

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumour in Patients With Metastatic Breast Cancer

Summary:

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.

Trial Description

Primary Outcome:

• Overall survival

Secondary Outcome:

• Uncontrolled chest wall disease
• Health-related quality of life

OBJECTIVES:
Primary

• 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. Secondary

• 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 tumour 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 tumour and blood specimens for future exploration of the biological interactions between the primary tumour and metastatic lesions and the effect of primary tumour resection.

OUTLINE:

This is a multicentre 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 tumour ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiation therapy 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 radiation therapy once a day, 5 days per week. Patients who had mastectomy undergo radiation therapy at the discretion of treating physician. Patients may undergo blood and tumour tissue sample collection for circulating tumour 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.

View this trial on ClinicalTrials.gov