Axillary Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes

November 20, 2015 updated by: Xiaoli Yu, Fudan University

Phase II Study of Axillary Level I-II Areas Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

475

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Early stage breast cancer patients with 1~2 positive sentinel lymph nodes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Axillary radiotherapy
Radiation: axillary radiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Axillary recurrence
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years
Disease free survival
Time Frame: 5 years
5 years
Complications
Time Frame: baseline，1，2，3，4，5 years
baseline，1，2，3，4，5 years
Local-regional recurrence
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xiaoli Yu, MD.PhD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

November 20, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-BC002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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