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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00002528




Registration number
NCT00002528
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
4/04/2013

Titles & IDs
Public title
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
Scientific title
Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.
Secondary ID [1] 0 0
IBCSG-10-93
Secondary ID [2] 0 0
CDR0000078383
Universal Trial Number (UTN)
Trial acronym
10-93
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tamoxifen citrate
Treatment: Surgery - conventional surgery
Treatment: Other - radiation therapy
Treatment: Surgery - Axillary clearance

Experimental: 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.

Experimental: 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.


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

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

Treatment: Other: 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.

Treatment: Surgery: Axillary clearance
Axillary node dissection.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free survival - Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
Timepoint [1] 0 0
17 years from randomization
Secondary outcome [1] 0 0
Overall survival - Time from randomization to death.
Timepoint [1] 0 0
17 years from randomization
Secondary outcome [2] 0 0
Toxicity - Side effects of treatment, especially surgery-related events.
Timepoint [2] 0 0
17 years from randomization
Secondary outcome [3] 0 0
Quality of life - Quality of life will be assessed by standard International Breast Cancer Study Group instruments
Timepoint [3] 0 0
17 years from randomization

Eligibility
Key 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 age
60 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital, Sydney - Sydney
Recruitment hospital [2] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Anti-Cancer Council of Victoria, Melbourne - Parkville
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital, Perth - Perth
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Hungary
State/province [1] 0 0
Budapest
Country [2] 0 0
Israel
State/province [2] 0 0
Jerusalem
Country [3] 0 0
Italy
State/province [3] 0 0
Aviano
Country [4] 0 0
Italy
State/province [4] 0 0
Brescia
Country [5] 0 0
Italy
State/province [5] 0 0
Gorizia
Country [6] 0 0
Italy
State/province [6] 0 0
Rimini
Country [7] 0 0
Italy
State/province [7] 0 0
Rome
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
Slovenia
State/province [9] 0 0
Ljubljana
Country [10] 0 0
South Africa
State/province [10] 0 0
Cape Town
Country [11] 0 0
Sweden
State/province [11] 0 0
Gothenburg (Goteborg)
Country [12] 0 0
Switzerland
State/province [12] 0 0
Basel
Country [13] 0 0
Switzerland
State/province [13] 0 0
Bern
Country [14] 0 0
Switzerland
State/province [14] 0 0
Lausanne
Country [15] 0 0
Switzerland
State/province [15] 0 0
St. Gallen
Country [16] 0 0
Switzerland
State/province [16] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Other
Name
International Breast Cancer Study Group
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00002528
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Diana Crivellari, MD
Address 0 0
Centro di Riferimento Oncologico - Aviano
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications