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

Breast Cancer Clinical Trial

— 10-93  

Official title:

Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002528
• Other study ID #: CDR0000078383
• Secondary ID: IBCSG-10-93EU-93
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: April 3, 2013
• Start date: May 1993
• Est. completion date: August 2010

Study information

• Verified date: July 2012
• Source: International Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: August 2010
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
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	Royal Prince Alfred Hospital, Sydney	Sydney	New South Wales
Australia	Newcastle Mater Misericordiae Hospital	Waratah	New South Wales
Hungary	National Institute of Oncology	Budapest
Israel	Hadassah University Hospital	Jerusalem
Italy	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
New Zealand	Auckland Adventist Hospital	Auckland
Slovenia	Institute of Oncology, Ljubljana	Ljubljana
South Africa	Groote Schuur Hospital, Cape Town	Cape Town
Sweden	Sahlgrenska University Hospital	Gothenburg (Goteborg)
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Kantonsspital - St. Gallen	St. Gallen
Switzerland	UniversitaetsSpital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
International Breast Cancer Study Group

Countries where clinical trial is conducted

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

References & Publications (2)

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 clearan — View Citation

Pestalozzi BC, Zahrieh D, Mallon E, Gusterson BA, Price KN, Gelber RD, Holmberg SB, Lindtner J, Snyder R, Thürlimann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall survival	Time from randomization to death.	17 years from randomization	No
Secondary	Toxicity	Side effects of treatment, especially surgery-related events.	17 years from randomization	Yes
Secondary	Quality of life	Quality of life will be assessed by standard International Breast Cancer Study Group instruments	17 years from randomization	No