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

NCT00072293 | Completed Results DMC

• 2 other identifiers: CDR0000339581IBCSG 23-01
• Study Type: interventional
• Target: 931
• Locations: 10 countries
• Sites: 31

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 5-year Overall Survival

  5-year estimate reported after a median follow-up of 60 months

• Site of Recurrence

  Reported after a median follow-up of 60 months

Study Arms (2)

Axillary Dissection

ACTIVE COMPARATOR

Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.

Procedure: Axillary lymph node dissection

No Axillary Dissection

EXPERIMENTAL

Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.

Procedure: No axillary lymph node dissection

Interventions

Axillary lymph node dissection PROCEDURE

Axillary lymph node dissection

Axillary Dissection

No axillary lymph node dissection PROCEDURE

Therapeutic conventional surgery

No Axillary Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ETOP IBCSG Partners Foundation: lead

Study Sites (31)

Lismore Base Hospital

Lismore, New South Wales, 2480, Australia

Location

St Vincents Hospital

Lismore, New South Wales, 2480, Australia

Location

Mater Hospital - North Sydney

North Sydney, New South Wales, 2060, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Riverina Cancer Care Centre

Wagga Wagga, New South Wales, 2650, Australia

Location

Westmead Institute for Cancer Research at Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital Cancer Centre

Adelaide, South Australia, 5000, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

St. John of God Hospital - Bunbury

Bunbury, Western Australia, 6230, Australia

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Horsholm Sygenus

Hørsholm, 2970, Denmark

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

University of Bologna Medical School

Bologna, 40138, Italy

Location

Universita di Ferrara

Ferrara, 44100, Italy

Location

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

Location

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Fondazione Salvatore Maugeri

Pavia, I-27100, Italy

Location

North Shore Hospital

Auckland, New Zealand

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, 34, Peru

Location

Institute of Oncology - Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 30196031 DERIVED

• 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.

  PMID: 23491275 DERIVED

Related Links

• Abstract from paper published in Lancet Oncology, 2013

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Rudolf Maibach, Executive Officer for International Trial Activities
• Organization: IBCSG

rudolf.maibach@ibcsg.org

+41 31 389 91 96

Study Officials

• Viviana E. Galimberti

  European Institute of Oncology

  STUDY CHAIR

• Umberto Veronesi, MD, Prof.

  European Institute of Oncology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: December 1, 2001
• Primary Completion: September 1, 2012
• Study Completion: March 31, 2017
• Last Updated: January 23, 2018
• Results First Posted: May 18, 2016

Record last verified: 2017-12

Locations

SL (1); FR (1); BR (1); NZ (2); DK (1); AU (10); CH (5); BE (1); PE (1); IT (8)