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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
For patients who met the inclusion criteria and were enrolled, postoperative tumor bed boost radiotherapy was waived, and only whole breast and/or regional lymph node irradiation was administered.
The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)
Nanjing, Jiangsu, China
RECRUITING5-year ipsilateral breast recurrence rate (IBTR)
The recurrence of the same-sided breast occurred for the first time within 5 years.
Time frame: 5 years
5-year local-regional recurrence (LRR)
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.
Time frame: 5 years
Local regional control rate (LRC)
The time from NAC to the occurrence of the first LRR
Time frame: 5 years
Disease-free survival time (DFS)
The time from NAC to recurrence or death
Time frame: 5 years
Overall survival time (OS)
The time from chemotherapy to death due to any cause
Time frame: 5 years
Safety-related study endpoints
acute or chronic radiotherapy-related adverse reactions: including skin damage, breast pain, lung damage, heart damage, upper limb edema, upper limb functional impairment, brachial plexus injury, etc.
Time frame: 5 years
cosmetic effect
evaluation of cosmetic effect after breast-conserving surgery using the Harvard standard.
Time frame: 5 years
quality of life evaluation
quality of life evaluation using the Chinese version of the QLQ-BR23 scale.
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Time frame: 5 years