Clinical trial NCT00002528: Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
Official title: Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 473
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 17 years from randomization
Secondary outcomes:
measure: Overall survival
timeFrame: 17 years from randomization
measure: Toxicity
timeFrame: 17 years from randomization
measure: Quality of life
timeFrame: 17 years from randomization
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital, Sydney
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Mater Misericordiae Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Parkville
country: Australia
facility: Anti-Cancer Council of Victoria, Melbourne
state: Victoria
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital, Perth
state: Western Australia
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
city: Brescia
country: Italy
facility: Spedali Civili
city: Gorizia
country: Italy
facility: Presidio Ospedaliero-Gorizia
city: Rimini
country: Italy
facility: Ospedale Civile Rimini
city: Rome
country: Italy
facility: Ospedale San Eugenio
city: Auckland
country: New Zealand
facility: Auckland Adventist Hospital
city: Ljubljana
country: Slovenia
facility: Institute of Oncology, Ljubljana
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital, Cape Town
city: Gothenburg (Goteborg)
country: Sweden
facility: Sahlgrenska University Hospital
city: Basel
country: Switzerland
facility: University Hospital
city: Bern
country: Switzerland
facility: Inselspital, Bern
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Zurich
country: Switzerland
facility: UniversitaetsSpital
Study officials:
affiliation: Centro di Riferimento Oncologico - Aviano
name: Diana Crivellari, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.