NCT00002528

Brief Summary

RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal. PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
473

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started May 1993

Longer than P75 for phase_3 breast-cancer

Geographic Reach
9 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1993

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

April 4, 2013

Status Verified

July 1, 2012

Enrollment Period

9.6 years

First QC Date

November 1, 1999

Last Update Submit

April 3, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.

    17 years from randomization

Secondary Outcomes (3)

  • Overall survival

    17 years from randomization

  • Toxicity

    17 years from randomization

  • Quality of life

    17 years from randomization

Study Arms (2)

Surgery w/ axillary clearance, tamox

EXPERIMENTAL

Either a total mastectomy with axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.

Drug: tamoxifen citrateProcedure: conventional surgeryRadiation: radiation therapyProcedure: Axillary clearance

Surgery w/o axillary clearance, tamox

EXPERIMENTAL

Either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.

Drug: tamoxifen citrateProcedure: conventional surgeryRadiation: radiation therapy

Interventions

tamoxifen citrateDRUG

20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.

Surgery w/ axillary clearance, tamoxSurgery w/o axillary clearance, tamox
conventional surgeryPROCEDURE

Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).

Surgery w/ axillary clearance, tamoxSurgery w/o axillary clearance, tamox
radiation therapyRADIATION

No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.

Surgery w/ axillary clearance, tamoxSurgery w/o axillary clearance, tamox
Axillary clearancePROCEDURE

Axillary node dissection.

Surgery w/ axillary clearance, tamox

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable * No prior axillary clearance or biopsy * Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed * Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign * No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 60 and over Sex: * Female Menopausal status * Postmenopausal Performance status: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.1 mg/dL * AST less than 60 U/L Renal: * Creatinine less than 1.3 mg/dL Cardiovascular: * Normal cardiac function * No history of congestive heart failure Other: * No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up * No psychiatric or addictive disorder that would preclude protocol therapy or informed consent * No other prior or concurrent malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix * Geographically accessible for follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for breast cancer Chemotherapy: * No prior chemotherapy for breast cancer Endocrine therapy: * No prior endocrine therapy for breast cancer Radiotherapy: * No prior radiotherapy for breast cancer Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (21)

Royal Prince Alfred Hospital, Sydney

Sydney, New South Wales, 2050, Australia

Location

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Anti-Cancer Council of Victoria, Melbourne

Parkville, Victoria, 3050, Australia

Location

Sir Charles Gairdner Hospital, Perth

Perth, Western Australia, 6009, Australia

Location

National Institute of Oncology

Budapest, 1125, Hungary

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Spedali Civili

Brescia, 25124, Italy

Location

Presidio Ospedaliero-Gorizia

Gorizia, 34170, Italy

Location

Ospedale Civile Rimini

Rimini, 47900, Italy

Location

Ospedale San Eugenio

Rome, 00144, Italy

Location

Auckland Adventist Hospital

Auckland, 5, New Zealand

Location

Institute of Oncology, Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Groote Schuur Hospital, Cape Town

Cape Town, 7925, South Africa

Location

Sahlgrenska University Hospital

Gothenburg (Goteborg), S-413 45, Sweden

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9006, Switzerland

Location

UniversitaetsSpital

Zurich, CH-8091, Switzerland

Location

Related Publications (2)

  • Pestalozzi BC, Zahrieh D, Mallon E, Gusterson BA, Price KN, Gelber RD, Holmberg SB, Lindtner J, Snyder R, Thurlimann B, Murray E, Viale G, Castiglione-Gertsch M, Coates AS, Goldhirsch A; International Breast Cancer Study Group. Distinct clinical and prognostic features of infiltrating lobular carcinoma of the breast: combined results of 15 International Breast Cancer Study Group clinical trials. J Clin Oncol. 2008 Jun 20;26(18):3006-14. doi: 10.1200/JCO.2007.14.9336. Epub 2008 May 5.

    PMID: 18458044BACKGROUND

  • International Breast Cancer Study Group; Rudenstam CM, Zahrieh D, Forbes JF, Crivellari D, Holmberg SB, Rey P, Dent D, Campbell I, Bernhard J, Price KN, Castiglione-Gertsch M, Goldhirsch A, Gelber RD, Coates AS. Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93. J Clin Oncol. 2006 Jan 20;24(3):337-44. doi: 10.1200/JCO.2005.01.5784. Epub 2005 Dec 12.

    PMID: 16344321RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TamoxifenRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTherapeutics

Study Officials

  • Diana Crivellari, MD

    Centro di Riferimento Oncologico - Aviano

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1993

Primary Completion

December 1, 2002

Study Completion

August 1, 2010

Last Updated

April 4, 2013

Record last verified: 2012-07

Locations

NZ(1)IT(5)IL(1)HU(1)CH(5)SE(1)AU(5)SL(1)ZA(1)