NCT01242800已完成不适用
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 749
- 主要终点
- 3-year Overall Survival Rate
研究概览
简要总结
RATIONALE: The primary tumor might be a source of re-seeding of distant sites and therefore elimination of this source of metastasizing cells by early local therapy may be of benefit.
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.
详细描述
OBJECTIVES:
Primary
- To evaluate whether early local therapy of intact primary disease in patients with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to patients who receive local therapy for palliation only.
Secondary
- To compare the time to uncontrolled chest wall disease between patients who receive early local therapy versus patients who receive palliative local therapy.
- To determine whether there is a difference in health-related quality-of-life (HRQOL) between patients who receive early local therapy versus patients who receive palliative local therapy.
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast
- •Stage IV disease
- •Confirmation of the primary tumor should be by needle biopsy (preferred)
- •Incisional surgical biopsy allowed as long as there is residual palpable or tumor image in the breast
- •Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
- •For women not undergoing axillary dissection, sentinel node biopsy should document an axillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may be applied)
- •Prior non-invasive (Ductal Carcinoma In Situ) cancer allowed provided there has been no recurrence
- •Prior ipsilateral invasive cancer allowed if more than 5 years previous
- •Patients should have at least one organ system involved with distant metastatic disease
- •If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available
- •Must have available radiologic reports documenting disease status within the past 6 weeks prior to initiating systemic therapy
- •CNS metastases allowed provided projected survival > 6 months
- •Patients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient's age and menopausal status)
- •If systemic therapy is discontinued for toxicity, but there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible
- •Radiation therapy (if indicated) must begin within 12 weeks of final therapeutic surgical procedure (including re-excision for free margins and completion of axillary dissection)
- •Patients may register at any time from the time of diagnosis of stage IV breast cancer (if eligibility criteria met) to the time when a maximum of 30 weeks of induction systemic therapy has been completed
- •Patients must be randomized within 16-32 weeks after the start of systemic therapy
- •Patients must not have experienced disease progression since the start of systemic therapy, as evidenced by radiographic documentation of disease status before treatment and within 4 weeks +/- 2 weeks prior to randomization, including:
- •No new sites of disease
- •No enlargement of existing sites by 20% or more in longest diameter
- •No symptomatic deterioration
- •Patients who require radiotherapy to bone metastases during induction systemic therapy are eligible
- •Local disease at the primary site must be asymptomatic
- •Hormone receptor status known
- •Menopausal status not specified
- •Patients must have adequate organ function to undergo local therapy 4 weeks +/- 2 weeks prior to randomization per investigator discretion and institutional guidelines
- •More than 5 years since other primary cancers that were curatively treated
- •Negative pregnancy test
- •Fertile patients must use an accepted and effective contraception method
- •Exclusion criteria:
- •Synchronous contralateral breast cancer
- •Pregnant or nursing
排除标准
- 未提供
结局指标
主要结局
3-year Overall Survival Rate
时间窗: Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years
Overall survival (OS) was 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. 3-year OS rate was estimated using Kaplan-Meier method.
次要结局
- 3-year Cumulative Incidence of Locoregional Recurrence/Progression(Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years)
- Health-related Quality of Life (HRQL)(Assessed at 18 months after randomization)
研究者
研究点 (749)
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