Clinical trial NCT02612012: Axillary Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
Official title: Phase II Study of Axillary Level I-II Areas Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
positive sentinel lymph nodes
axillary radiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 475
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Early stage breast cancer patients with 1\~2 positive sentinel lymph nodes

Brief summary: This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.

Detailed description: Randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. However, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. The purpose of this study is to evaluate the feasibility and safety of axillary level I-II areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.

Eligibility criteria: Inclusion Criteria:

* Female
* 18\~70 years old
* Pathologically confirmed invasive breast cancer
* A clinical T1-2N0M0 tumor
* Treated with breast conserving surgery and sentinel lymph node biopsy
* 1\~2 positive sentinel lymph nodes, including micro-metastases or macro-metastases.
* ECOG score 1\~2
* Written informed consent

Exclusion Criteria:

* Patients underwent complete axillary lymph node dissection
* Patients underwent mastectomy
* Patients underwent neoadjuvant therapy
* Clinically node positive pre-operative
* Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm)
* Prior history of invasive breast cancer or previous or concurrent other malignancies within the past 5 years
* Previous radiation therapy of breast or thorax
* Medical contraindication for radiotherapy
* Prior axillary surgery or radiotherapy
* Unable or unwilling to receive breast conserving surgery or sentinel lymph node biopsy
* Pregnant or nursing

Primary outcomes:
measure: Axillary recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Local-regional recurrence
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Complications
timeFrame: baseline，1，2，3，4，5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Xiaoli Yu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: