Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of Patients with Progression-Free Survival (PFS)
研究概览
简要总结
The goal of this clinical research study is to find out if adding local therapy (surgery and/or radiation) to standard therapy (chemotherapy or endocrine therapy) in the treatment of patients with metastatic breast cancer can help to control the disease for a longer period of time than standard therapy alone.
详细描述
Study Treatments:
Current standard of care for breast cancer patients whose disease has spread to the bones is to treat them with chemotherapy or endocrine therapy. However, using radiation and surgery as well may help to get rid of the cancer cells in the bone lesions.
All participants will receive separate consent documents to sign that will explain the routine surgery, radiation therapy, and chemotherapy.
Standard Therapy:
If the imaging scans show that you are not at increased risk for bone fracture, you will receive 3 to 9 months of systemic therapy that is most appropriate for you as decided by your doctor. You may also be placed on endocrine therapy as decided by your doctor. If you have received drugs in the past that could cause heart-related side effects and/or a history of heart disease, you may have heart function tests, if your cancer doctor decides it is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer with metastasis to skeletal sites only
- •1 to 3 bone metastatic sites (metastatic lesions in the same bone that are within 3 cm of each other are considered as one site)
- •KPS greater than or equals to 70
- •Absolute neutrophil count of > 1500 per microliter and platelet count > 100,000 per microliter; AST and alkaline phosphatase < = 2.5 X normal limits, bilirubin < = 1.5 x normal limits, calculated creatinine clearance > 50 ml/min using Cockcroft-Gault formula: CrCl male = (140-age) x (wt. in kg)/(Serum Cr x 72); CrCl female = 0.85 x (CrCl male)
- •Patients may or may not have started bis-phosphonates.
- •Patients who have received prior chemotherapy for their original breast cancer treatment are still eligible.
- •Previous use of systemic therapy for bone metastasis is allowable as long as the systemic therapy use fits within the treatment plan as described in Proposed Treatment/Study Plan. (If the patient received less than 3 - 9 months of systemic therapy previously, the use of additional systemic therapy may be necessary to fit within the treatment plan)
- •Treating physician assesses tumor to be sufficiently distant from sensitive structures to be able to achieve greater than or equal to 66 Gy. (i.e., spinal cord tolerance respected in vertebral body metastasis.
- •Patients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy. Otherwise systemic therapy should be given first as outlined in abstract treatment study plan sections 1 and 2.
排除标准
- •Distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
- •Prior radiation to site(s) of distant metastasis of bone
- •History of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment
- •Second primary malignancy (skin cancer other than melanoma allowed) that is disease free for less than 3 years
- •Premenopausal and postmenopausal (amenorrheic for less than 12 months) women with either a positive or no pregnancy test (serum or urine) at baseline within 7 days study enrollment. Postmenopausal women who are amenorrheic for more than 12 months do not require pregnancy test.
- •Women with child-bearing potential not using a reliable an appropriate contraceptive method.
- •Patients with child-bearing potential will agree to use contraception while on study and for 30 days from the date of the last therapy on protocol.
- •If the patient requires surgery of the bone metastasis, clinically serious comorbidities that render patient not medically fit for surgery (e.g. congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias and chronic lung disease not well controlled with medication; myocardial infarction within 12 months of enrollment)
- •Central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant to preclude informed consent or interfere with complying with protocol treatments.
研究组 & 干预措施
Standard Therapy + Local Therapy
Systemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation)
干预措施: Standard Therapy (Drug)
Standard Therapy + Local Therapy
Systemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation)
干预措施: Local Therapy (Procedure)
结局指标
主要结局
Number of Patients with Progression-Free Survival (PFS)
时间窗: 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.
次要结局
未报告次要终点