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

NCT ID: NCT00002528

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-05-31
• Study Completion Date: 2010-08-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery w/ axillary clearance, tamox

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.

Group Type: EXPERIMENTAL

tamoxifen citrate

Intervention Type: DRUG

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

conventional surgery

Intervention Type: PROCEDURE

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

radiation therapy

Intervention Type: RADIATION

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.

Axillary clearance

Intervention Type: PROCEDURE

Axillary node dissection.

Surgery w/o axillary clearance, tamox

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.

Group Type: EXPERIMENTAL

tamoxifen citrate

Intervention Type: DRUG

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

conventional surgery

Intervention Type: PROCEDURE

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

radiation therapy

Intervention Type: RADIATION

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.

Interventions

tamoxifen citrate

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

Intervention Type: DRUG

conventional surgery

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

Intervention Type: PROCEDURE

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.

Intervention Type: RADIATION

Axillary clearance

Axillary node dissection.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ETOP IBCSG Partners Foundation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana Crivellari, MD

Role: STUDY_CHAIR

Centro di Riferimento Oncologico - Aviano

Locations

Royal Prince Alfred Hospital, Sydney

Sydney, New South Wales, Australia

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Anti-Cancer Council of Victoria, Melbourne

Parkville, Victoria, Australia

Sir Charles Gairdner Hospital, Perth

Perth, Western Australia, Australia

National Institute of Oncology

Budapest, , Hungary

Hadassah University Hospital

Jerusalem, , Israel

Centro di Riferimento Oncologico - Aviano

Aviano, , Italy

Spedali Civili

Brescia, , Italy

Presidio Ospedaliero-Gorizia

Gorizia, , Italy

Ospedale Civile Rimini

Rimini, , Italy

Ospedale San Eugenio

Rome, , Italy

Auckland Adventist Hospital

Auckland, , New Zealand

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

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

UniversitaetsSpital

Zurich, , Switzerland

Countries

Australia; Hungary; Israel; Italy; New Zealand; Slovenia; South Africa; Sweden; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 18458044 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16344321 (View on PubMed)

Other Identifiers

IBCSG-10-93

Identifier Type: -

Identifier Source: secondary_id

EU-93013

Identifier Type: -

Identifier Source: secondary_id

NCI-F93-0008

Identifier Type: -

Identifier Source: secondary_id

CDR0000078383

Identifier Type: -

Identifier Source: org_study_id