Axillary Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
Phase II Study of Axillary Level I-II Areas Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
1 other identifier
observational
475
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedNovember 23, 2015
November 1, 2015
4 years
November 19, 2015
November 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Axillary recurrence
5 years
Secondary Outcomes (4)
Local-regional recurrence
5 years
Disease free survival
5 years
Overall survival
5 years
Complications
baseline，1，2，3，4，5 years
Study Arms (1)
Axillary radiotherapy
Interventions
Whole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week.
Eligibility Criteria
Early stage breast cancer patients with 1\~2 positive sentinel lymph nodes
You may qualify if:
- Female
- \~70 years old
- Pathologically confirmed invasive breast cancer
- A clinical T1-2N0M0 tumor
- Treated with breast conserving surgery and sentinel lymph node biopsy
- \~2 positive sentinel lymph nodes, including micro-metastases or macro-metastases.
- ECOG score 1\~2
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoli Yu, MD.PhD
Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of department of radiation oncology
Study Record Dates
First Submitted
November 19, 2015
First Posted
November 23, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2019
Last Updated
November 23, 2015
Record last verified: 2015-11