Clinical trial NCT00072293: Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: stage IA breast cancer
stage IB breast cancer
stage II breast cancer
estrogen receptor-negative breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer
progesterone receptor-positive breast cancer
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
First posted: 2003-11-06
Enrollment: 931
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 5-year Disease-Free Survival
timeFrame: 5-year estimate reported after a median follow-up of 60 months
Secondary outcomes:
measure: 5-year Overall Survival
timeFrame: 5-year estimate reported after a median follow-up of 60 months
measure: Site of Recurrence
timeFrame: Reported after a median follow-up of 60 months
Other outcomes:
Locations:
city: Lismore
country: Australia
facility: Lismore Base Hospital
state: New South Wales
city: Lismore
country: Australia
facility: St Vincents Hospital
state: New South Wales
city: North Sydney
country: Australia
facility: Mater Hospital - North Sydney
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Cancer Centre at Royal Prince Alfred Hospital
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Riverina Cancer Care Centre
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Institute for Cancer Research at Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital Cancer Centre
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Bunbury
country: Australia
facility: St. John of God Hospital - Bunbury
state: Western Australia
city: Liege
country: Belgium
facility: CHU Liege - Domaine Universitaire du Sart Tilman
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Horsholm
country: Denmark
facility: Horsholm Sygenus
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Bologna
country: Italy
facility: University of Bologna Medical School
city: Ferrara
country: Italy
facility: Universita di Ferrara
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni
city: Milan
country: Italy
facility: Istituto Scientifico H. San Raffaele
city: Milan
country: Italy
facility: European Institute of Oncology
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Ljubljana
country: Slovenia
facility: Institute of Oncology - Ljubljana
city: Aarau
country: Switzerland
facility: Kantonspital Aarau
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
Study officials:
affiliation: European Institute of Oncology
name: Viviana E. Galimberti
role: STUDY_CHAIR
affiliation: European Institute of Oncology
name: Umberto Veronesi, MD, Prof.
role: STUDY_CHAIR
References:
citation: Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5.
citation: Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11.