A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Ipsilateral breast tumor recurrence rates
研究概览
简要总结
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence rates. Patients will be followed for a period of five years following completion of radiation to determine these rates.
II. To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation.
SECONDARY OBJECTIVES:
I. To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy in the setting of multi-centric disease.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm)
- •All radiographically suspicious lesions must be biopsied and have histologically confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary, papillary, colloid (mucinous), or tubular histologies
- •A maximum of two radiographically detected malignant lesions
- •Clinical Stage I-II breast carcinoma, with lesion size =< 5 cm for the dominant mass and the second lesion detected only on MRI, treated with lumpectomies; the MRI detected lesion must be pathologically =< 1 cm
- •Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary dissection as deemed appropriate by the treating surgeon for all patients with invasive cancer; no axillary lymph node sampling is needed for patients with DCIS
- •Negative resection margins with at least a 2 mm margin from invasive and in-situ cancer or a negative re-excision
- •A posterior margin =< 2 mm from DCIS is permissible provided fascia was taken
- •Patients are eligible regardless of estrogen receptor, progesterone receptor, or Her-2/neu amplification
- •Hormonal therapy is allowed; if adjuvant chemotherapy is planned, the chemotherapy should be delivered first and radiation must begin no earlier than three weeks and no later than eight weeks following completion of chemotherapy
- •Signed study-specific informed consent prior to study entry
- •Extensive intraductal component by the Harvard definition (i.e., more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue)
- •Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
- •Patients receiving neoadjuvant chemotherapy
- •Patients with distant metastatic disease detected by radiographic imaging; specific studies for systemic imaging should be obtained as directed by localized symptoms or per available NCCN guidelines
- •Patients with known BRCA 1/BRCA 2 mutations or those with predicted risk of carrying the mutation by BRCAPRO (44) risk assessment >= 50%
- •Diffuse calcifications throughout the breast
- •Patients with skin involvement or inflammatory breast cancer
- •Patients with Paget's disease of the nipple
- •Patients nonepithelial breast malignancies such as lymphoma or sarcoma
- •Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis
- •Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
- •Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study
- •Patients who are pregnant or lactating, due to potential fetal exposure to radiation and unknown effects of radiation on lactating females
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: external beam radiation therapy (Radiation)
Arm I
Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: questionnaire administration (Other)
Arm I
Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Ipsilateral breast tumor recurrence rates
时间窗: 5 years after completion of radiation
Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation
时间窗: at 1 year after radiation
次要结局
- To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy(5 years after completion of radiation treatment)
- Patient satisfaction with the procedure as determined by a questionnaire(at 1 year after radiation)
- To evaluate wound healing and overall complication rate after radiation(at one year after radiation)