Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

473

Participants

Timeline

Start Date

May 31, 1993

Primary Completion Date

December 31, 2002

Study Completion Date

August 31, 2010

Conditions
Breast Cancer
Interventions
DRUG

tamoxifen citrate

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

PROCEDURE

conventional surgery

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

RADIATION

radiation therapy

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.

PROCEDURE

Axillary clearance

Axillary node dissection.

Trial Locations (21)

5

Auckland Adventist Hospital, Auckland

1125

National Institute of Oncology, Budapest

2050

Royal Prince Alfred Hospital, Sydney, Sydney

2298

Newcastle Mater Misericordiae Hospital, Waratah

3050

Anti-Cancer Council of Victoria, Melbourne, Parkville

5000

Royal Adelaide Hospital, Adelaide

6009

Sir Charles Gairdner Hospital, Perth, Perth

7925

Groote Schuur Hospital, Cape Town, Cape Town

25124

Spedali Civili, Brescia

33081

Centro di Riferimento Oncologico - Aviano, Aviano

34170

Presidio Ospedaliero-Gorizia, Gorizia

47900

Ospedale Civile Rimini, Rimini

91120

Hadassah University Hospital, Jerusalem

00144

Ospedale San Eugenio, Rome

Sl-1000

Institute of Oncology, Ljubljana, Ljubljana

S-413 45

Sahlgrenska University Hospital, Gothenburg (Goteborg)

CH-4031

University Hospital, Basel

CH-3010

Inselspital, Bern, Bern

CH-1011

Centre Hospitalier Universitaire Vaudois, Lausanne

CH-9006

Kantonsspital - St. Gallen, Sankt Gallen

CH-8091

UniversitaetsSpital, Zurich

All Listed Sponsors
lead

ETOP IBCSG Partners Foundation

NETWORK