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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: tamoxifen citrate; Procedure: conventional surgery; Radiation: radiation therapy; Procedure: Axillary clearance

• Registration Number: NCT00002528
• Lead Sponsor: ETOP IBCSG Partners Foundation

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.

Detailed Description

OBJECTIVES:

* Compare local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection.

* Compare the toxicity of these regimens in these patients.

* Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.

* Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo sentinel node biopsy.

* Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then receive oral tamoxifen for 5 years.

Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence in the conserved breast, patients undergo total mastectomy; those in arm II who experience ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up are continued.

Quality of life is assessed.

Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within approximately 5 years.

Study Timeline

• Study Start: 1993-05
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2010-08
• Status Verified: 2012-07
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 473

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery w/ axillary clearance, tamox	tamoxifen citrate	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.
Surgery w/o axillary clearance, tamox	tamoxifen citrate	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.
Surgery w/o axillary clearance, tamox	conventional surgery	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.
Surgery w/o axillary clearance, tamox	radiation therapy	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.
Surgery w/ axillary clearance, tamox	conventional surgery	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.
Surgery w/ axillary clearance, tamox	radiation therapy	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.
Surgery w/ axillary clearance, tamox	Axillary clearance	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	17 years from randomization	Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Overall survival	17 years from randomization	Time from randomization to death.
Quality of life	17 years from randomization	Quality of life will be assessed by standard International Breast Cancer Study Group instruments
Toxicity	17 years from randomization	Side effects of treatment, especially surgery-related events.

Trial Locations

Locations (21)

Royal Prince Alfred Hospital, Sydney; 🇦🇺 Sydney, New South Wales, Australia

Sir Charles Gairdner Hospital, Perth; 🇦🇺 Perth, Western Australia, Australia

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel

Auckland Adventist Hospital; 🇳🇿 Auckland, New Zealand

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

National Institute of Oncology; 🇭🇺 Budapest, Hungary

Spedali Civili; 🇮🇹 Brescia, Italy

Anti-Cancer Council of Victoria, Melbourne; 🇦🇺 Parkville, Victoria, Australia

Newcastle Mater Misericordiae Hospital; 🇦🇺 Waratah, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Centro di Riferimento Oncologico - Aviano; 🇮🇹 Aviano, Italy

Presidio Ospedaliero-Gorizia; 🇮🇹 Gorizia, Italy

Ospedale Civile Rimini; 🇮🇹 Rimini, Italy

Ospedale San Eugenio; 🇮🇹 Rome, Italy

Institute of Oncology, Ljubljana; 🇸🇮 Ljubljana, Slovenia

Groote Schuur Hospital, Cape Town; 🇿🇦 Cape Town, South Africa

Sahlgrenska University Hospital; 🇸🇪 Gothenburg (Goteborg), Sweden

University Hospital; 🇨🇭 Basel, Switzerland

Inselspital, Bern; 🇨🇭 Bern, Switzerland

UniversitaetsSpital; 🇨🇭 Zurich, Switzerland