Partial Breast Re-irradiation in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation: a Prospective Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Treatment related toxicity
研究概览
简要总结
A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer
详细描述
Breast cancer is the leading type of cancer in women worldwide. Although advances in treatment have led to an overall reduction in breast cancer mortality, survivors continue to have an ongoing risk of disease recurrence. For women who experience breast recurrence, mastectomy has historically been the only treatment approach offered. However, it has been associated with negative health outcomes, including reduced quality of life, depression and anxiety, and impaired sexual functioning. As a result, there is increasing interest to identify treatment options that include breast preservation. Breast-conserving surgery followed by re-irradiation with partial breast irradiation has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Isolated ipsilateral unifocal breast lesions;
- •Histologically confirmed invasive breast carcinoma or carcinoma in situ;
- •Limited size (< 2 cm) without evidence of skin involvement;
- •Negative histologic margins of resection;
- •Negative axillary lymph nodes;
- •No synchronous distant metastases;
- •Bilateral breast mammogram or MRI within 120 days prior to study entry;
- •For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan (if clinically relevant);
- •≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence;
- •Female, aged >18 years;
- •Life expectancy of greater than 12 months;
- •ECOG performance status <2;
- •Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter;
- •Participant is willing and able to give informed consent for participation in the study;
排除标准
- •Regional recurrences (axillary, supraclavicular);
- •Positive histologic margins at resection;
- •Metastatic disease;
- •Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;
- •Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;
- •Patients who had chemotherapy within 2 weeks prior to study RT;
- •Participation in another clinical trial with any investigational agents within 30 days prior to study screening;
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
- •Significant comorbidity precluding RT for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus);
- •Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix, endometrium or colon);
- •Inaccessibility for follow-up;
研究组 & 干预措施
Partial breast re-irradiation
partial breast re-irradiation in patients with local recurrence of breast cancer, previously treated with breast conservative surgery and whole breast radiotherapy. A total dose of 35 Gy in 10 daily fractions, 5 fractions per week, will be prescribed.
干预措施: Partial breast re-irradiation (Radiation)
结局指标
主要结局
Treatment related toxicity
时间窗: 12 months
determine the toxicity of partial breast re-irradiation (PBrI) as rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain Adverse Events, accordin to Common Terminology Criteria for Adverse Events scale 5.0 (Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE) up to 1 year from completion of radiation treatment
次要结局
- in-breast recurrence in the ipsilateral breast(5 years)
- Number of patients free from mastectomy over total number of patients(5 years)
- To evaluate distant-metastasis free survival(5 years)
- Overall survival(5 years)
- Patient satisfaction(5 years)