A Multicenter, Single-arm Phase II Clinical Study on Exempting Tumor Bed Boost Radiotherapy for Patients Achieving pCR After Breast Conserving Surgery With Neoadjuvant Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 5-year ipsilateral breast recurrence rate (IBTR)
研究概览
简要总结
This study is a multicenter, single-arm, phase II clinical trial, aiming to evaluate the safety and efficacy of tumor bed dose escalation radiotherapy for patients with primary breast lesions achieving pCR (ypT0) after neoadjuvant chemotherapy and breast-conserving surgery.
详细描述
New neoadjuvant chemotherapy (NAC) is mainly used for patients with locally advanced or those who wish to preserve their breast. It not only helps to downstage the tumor but also increases the success rate and possibility of breast-conserving treatment for patients. Moreover, NAC provides doctors with the opportunity to assess the chemotherapy response, which can be used to predict the survival of patients. Studies have shown that patients who achieve pathological complete response (PCR) after NAC and surgery have a lower local-regional recurrence rate, higher disease-free survival rate and overall survival rate. Currently, there are no treatment guidelines for this group of patients. Avoiding unnecessary tumor bed dose escalation can reduce radiotherapy toxicity and help promote the effective utilization of medical resources. This study is the first prospective single-arm study to explore the prognostic significance of NAC and breast-conserving surgery without tumor bed dose escalation for patients with pCR breast cancer. The aim is to identify the appropriate population for exemption from tumor bed dose escalation and to develop more precise adjuvant radiotherapy plans.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) Voluntary participation, good compliance, able to cooperate with the trial observation, and having signed a written informed consent form; (2) Confirmed as invasive cancer through pathological tissue examination, and received baseline breast MR or PET/MR examination before neoadjuvant therapy; (3) Received the standard neoadjuvant treatment plan recommended by the guidelines based on molecular typing; (4) Single lesion, initially diagnosed as cT1-3N0-3a; (5) Underwent breast-conserving surgery, with negative surgical margins and a margin distance of ≥1mm, and achieved pCR of the primary breast lesion after NAC (ypT0); (6) Age 30-75 years, ECOG score 0-1; (7) Met the basic requirements for adjuvant radiotherapy, including basically normal peripheral blood count, no significant abnormalities in heart, liver, and kidney functions, and basically normal electrocardiogram; (8) Had no previous chest radiotherapy.
排除标准
- •(1) Pregnant women, lactating women, or women with reproductive capacity but without contraceptive measures in place; (2) Known to carry mutated susceptibility genes for breast cancer (including BRCA-1 and BRCA-2); (3) Diagnosed with cT4, N3b-c, bilateral breast cancer, with multiple primary lesions, multicentricity or non-bulky enhancement at the primary site; (4) Not receiving the standard neoadjuvant treatment regimen recommended by guidelines, or the primary breast lesion did not achieve pCR (including ypTis) after NAC; (5) Suffering from other malignant tumors or participating in other clinical trials simultaneously; (6) Unable to start radiotherapy within 8 weeks after breast cancer surgery; (7) Diagnosed with distant metastasis through initial imaging or pathology; (8) Previous history of breast cancer, history of radiotherapy in the neck, chest or ipsilateral axilla; (9) Severe non-tumor-related medical comorbidities affecting the implementation of radiotherapy; (10) Suffering from uncontrollable neurological, mental disorders or mental impairments, with poor compliance and inability to cooperate and describe treatment responses.
研究组 & 干预措施
Exempted tumor bed radiotherapy group
The total breast irradiation dose was 43.5 Gy/15 fractions, with each fraction being 2.9 Gy, administered once a day, 5 times a week; the dose for the regional lymph nodes was also 43.5 Gy/15 fractions, with each fraction being 2.9 Gy, administered once a day, 5 times a week.
干预措施: Exemption from additional radiotherapy on the tumor bed after surgery (Radiation)
结局指标
主要结局
5-year ipsilateral breast recurrence rate (IBTR)
时间窗: 5 years
The recurrence of the same-sided breast occurred for the first time within 5 years.
5-year local-regional recurrence (LRR)
时间窗: 5 years
Recurrence of the same-side breast, the same-side axillary fossa, the same-side supraclavicular lymph nodes, or the same-side internal mammary lymph nodes for the first time within 5 years.
次要结局
- Local regional control rate (LRC)(5 years)
- Disease-free survival time (DFS)(5 years)
- Overall survival time (OS)(5 years)
- Safety-related study endpoints(5 years)
- cosmetic effect(5 years)
- quality of life evaluation(5 years)
研究者
Sun Xinchen
Director of the Radiotherapy Center
The First Affiliated Hospital with Nanjing Medical University