Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases

Breast Cancer Clinical Trial

— 23-01  

Official title:

A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072293
• Other study ID #: CDR0000339581
• Secondary ID: IBCSG 23-01
• Status: Completed
• Phase: N/A
• First received: November 4, 2003
• Last updated: December 22, 2017
• Start date: December 2001
• Est. completion date: March 31, 2017

Study information

• Verified date: December 2017
• Source: International Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

Description:

OBJECTIVES:

• Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.

• Compare overall survival of patients treated with these regimens.

• Assess sites of recurrence, particularly reappearance of disease in the undissected axilla.

• Assess long-term surgical complications in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 931
• Est. completion date: March 31, 2017
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma

• Largest tumor lesion = 5 cm

• Palpable or nonpalpable breast lesion

• Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions

• Prior (preoperative) or planned (intraoperative) sentinel node biopsy required

• At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension

• No clinical evidence of distant metastases

• No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:

• Skeletal pain of unknown cause

• Elevated alkaline phosphatase

• Bone scan showing hot spots

• No palpable axillary lymph node(s)

• No Paget's disease without invasive cancer

• Hormone receptor status:

• Estrogen receptor and progesterone receptor known

PATIENT CHARACTERISTICS:

Age

• Any age

Sex

• Female

Menopausal status

• Any status

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• See Disease Characteristics

Renal

• Not specified

Other

• Not pregnant or nursing

• No other prior or concurrent malignancy except the following:

• Adequately treated basal cell or squamous cell skin cancer

• Adequately treated carcinoma in situ of the cervix

• Adequately treated in situ melanoma

• Contralateral or ipsilateral carcinoma in situ of the breast

• No psychiatric, addictive, or other disorder that may compromise ability to give informed consent

• Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• No prior systemic therapy for breast cancer

• More than 1 year since prior chemopreventive agent

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Axillary lymph node dissection
Axillary lymph node dissection
• No axillary lymph node dissection
Therapeutic conventional surgery

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital Cancer Centre	Adelaide	South Australia
Australia	St. John of God Hospital - Bunbury	Bunbury	Western Australia
Australia	Lismore Base Hospital	Lismore	New South Wales
Australia	St Vincents Hospital	Lismore	New South Wales
Australia	Mater Hospital - North Sydney	North Sydney	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Sydney Cancer Centre at Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	Riverina Cancer Care Centre	Wagga Wagga	New South Wales
Australia	Westmead Institute for Cancer Research at Westmead Hospital	Westmead	New South Wales
Belgium	CHU Liege - Domaine Universitaire du Sart Tilman	Liege
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Denmark	Horsholm Sygenus	Horsholm
France	Institut Gustave Roussy	Villejuif
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	University of Bologna Medical School	Bologna
Italy	Universita di Ferrara	Ferrara
Italy	Ospedale Alessandro Manzoni	Lecco
Italy	European Institute of Oncology	Milan
Italy	Istituto Scientifico H. San Raffaele	Milan
Italy	Fondazione Salvatore Maugeri	Pavia
New Zealand	North Shore Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Slovenia	Institute of Oncology - Ljubljana	Ljubljana
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona
Switzerland	Inselspital Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Kantonsspital - St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
International Breast Cancer Study Group

Countries where clinical trial is conducted

Australia,  Belgium,  Brazil,  Denmark,  France,  Italy,  New Zealand,  Peru,  Slovenia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year Disease-Free Survival	Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.	5-year estimate reported after a median follow-up of 60 months
Secondary	5-year Overall Survival	Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.	5-year estimate reported after a median follow-up of 60 months
Secondary	Site of Recurrence	Site of recurrence of breast cancer	Reported after a median follow-up of 60 months

External Links

•   Abstract from paper published in Lancet Oncology, 2013