Sentinel Node Biopsy in Breast Cancer Patients

May 27, 2011 updated by: Uppsala University

Cohort Study of Axillary Recurrences and Survival After Negative Negative Sentinel Node Biopsy Without Completion Axillary Clearance

Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure in breast cancer patients. However, ALND is accompanied by a considerable morbidity, and sentinel lymph node biopsy (SLNB) evolved as a mean to decrease this morbidity. Between September 2000 and January 2004 breast cancer patients were included in the Swedish Sentinel Node Multicenter Cohort Study with the intent of studying axillary recurrence after negative SLNB for patients in which completion ALND were omitted. The patients were followed prospectively and events (local, regional and distant recurrences and deaths) were registered. The primary endpoint was axillary recurrence and secondary endpoints were disease-free, cancer-specific and overall survival.

Study Overview

Status

Completed

Detailed Description

Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure in breast cancer patients. However, ALND is accompanied by a considerable morbidity, including seroma formation, lymphedema, neuropathy of the arm with numbness, stiffness, impaired shoulder movement and pain. Sentinel lymph node biopsy (SLNB) has evolved as a mean to decrease this morbidity, and validation studies have demonstrated the accuracy of the method.

With the intent of studying axillary recurrence after negative SLNB for patients in which completion ALND were omitted, consecutive breast cancer patients were included in the Swedish Sentinel Node Multicenter Cohort Study between September 2000 and January 2004.

Patients with a unifocal, invasive breast cancer less than 3 cm in diameter were eligible for enrollment. Exclusion criteria were palpable regional lymph nodes, neoadjuvant chemo- or radiotherapy, pregnancy, known allergic reactions to blue dye or isotope, previous surgery in the ipsilateral breast, and preoperatively diagnosed tumor multifocality.

Surgical procedure:

After the preoperative injection of 40-60 mBq Technetium-99 nanocolloid (Solco Nanocoll®) and 1 ml blue dye (Patent Blue V®), sentinel lymph node (SLN) biopsy was performed. If no sentinel node could be identified, ALND of levels I and II was performed. A completion ALND was also performed in the event of a positive SLN biopsy, if lymph nodes clearly suspicious of metastasis were detected during surgery, or if the primary tumor in the breast was found to be multifocal on pathological examination.

Pathological assessment:

Frozen sections were obtained from each SLN and examined peroperatively. If a sentinel lymph node was smaller than 4 mm, two sections were analyzed separately. Nodes larger than 4 mm were bisected, and two sections from each half analyzed. According to the study protocol, at least three sections were prepared from the sentinel node or each part of a bisected node for definitive histopathology. Sections were stained with haematoxylin and eosin (HE). If no cancer cells were detected, immunohistochemistry (IHC) with cytokeratin antibodies was also performed.

Non-sentinel lymph nodes were examined by routine staining (HE) according to the protocol of each pathology department.

Treatment and follow-up:

Adjuvant treatment combinations were given according to national and regional treatment guidelines, based on tumor characteristics, lymph node status, and surgical treatment. Patients with isolated tumor cells were regarded as lymph node-negative. If breast-conserving surgery had been performed, radiation therapy to the breast was given, which was extended to include the regional lymph nodes in case of axillary lymph node metastases.

Chemotherapy was offered to all patients with lymph node metastases or those with a combination of unfavorable primary tumor characteristics (large tumor, high Elston score, progesterone receptor negativity), after consideration of their general health. Endocrine therapy was offered to all patients with estrogen or progesterone receptor-positive tumors larger than 10 mm. The actual reported adjuvant treatment is controlled for in the analyses.

Patients were followed prospectively. The research protocol postulated an annual follow-up with mammography and clinical examination.

After enrollment, data sheets, including information on primary tumor characteristics, number of sentinel and non-sentinel lymph nodes with and without metastasis, and given adjuvant treatment, were computerized. The study was approved by the ethics committee of Karolinska Institutet, Stockholm, and each region's local ethics committee. All patients gave written informed consent.

Study Type

Observational

Enrollment (Actual)

3369

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

      • Västerås, Sweden, 72189
        • Centre for Clinical Research, Uppsala University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with primary breast cancer in Swedish hospitals

Description

Inclusion Criteria:

  • Primary invasive breast cancer

Exclusion Criteria:

  • Preoperatively diagnosed axillary metastases
  • Multifocal tumors
  • Tumors > 3 cm
  • Impalpable tumors
  • Earlier resection of the tumor
  • Neoadjuvant treatment
  • Pregnancy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axillary recurrence after negative sentinel node biopsy
Time Frame: 5 years
Prospective follow-up of axillary recurrences in patients with negative sentinel lymph node biopsy in which completion axillary lymph node dissection were omitted
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 5 years
Survival (disease-free, cancer-specific and overall) in the sentinel lymph node biopsy cohort
5 years

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Leif Bergkvist, M.D. Ph.D., Centre for Clinical Research, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

September 1, 2000

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 30, 2011

Last Update Submitted That Met QC Criteria

May 27, 2011

Last Verified

June 1, 2000

More Information

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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