Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00003855




Registration number
NCT00003855
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
29/04/2020

Titles & IDs
Public title
Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer
Scientific title
A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
Secondary ID [1] 0 0
GUMC-00153
Secondary ID [2] 0 0
ACOSOG-Z0011
Universal Trial Number (UTN)
Trial acronym
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
Experimental: Surgery + radiotherapy - Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes, followed by whole-breast radiotherapy (exclusive of a third supraclavicular field) 5 days a week for a maximum of 7 weeks. Patients may receive adjuvant systemic therapy at the discretion of the treating physician.

Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.

Active comparator: Radiotherapy - Patients undergo breast radiotherapy only. Patients may receive adjuvant systemic therapy at the discretion of the treating physician.

Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Up to 10 years
Primary outcome [2] 0 0
Morbidity
Timepoint [2] 0 0
Up to 10 years
Primary outcome [3] 0 0
Disease-free survival
Timepoint [3] 0 0
Up to 10 years

Eligibility
Key inclusion criteria
PLEASE NOTE: Patients registered to this study may undergo intra-operative or post¬operative randomization.

1. Patient must be female.
2. Patient must be at least 18 years of age.
3. Patient's clinical stage must be documented as tumor size less than 5 cm, with no palpable nodes and no evidence of metastatic disease (T1 or T2 N0 M0; see appendices for staging criteria) and the tumor documented as amenable to lumpectomy.
4. Patient must have a tissue diagnosis of invasive breast carcinoma. Note: A patient can be registered to this study if they have a cytologic diagnosis suggestive of carcinoma from a fine needle aspiration (FNA) of a palpable or non-palpable breast lesion and the investigator believes the breast lesion is clinically suspicious for invasive breast carcinoma.
5. Date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of carcinoma must be no more than 60 days prior to the SLND.
6. The patient who had BCT (segmental mastectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the BCT was less than or equal to 60 days prior to the SLND. NOTE: Copies of the operative and pathology reports must be submitted as part of the registration process.
7. Patient must have ECOG/Zubrod status =2, as documented in patient's medical record.
8. Patient must be available for follow-up.
9. Patient of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
10. Patient must have access to radiation therapy.
11. A sentinel lymph node must be identified that contains metastatic breast cancer as documented by frozen section, touch prep, or H&E staining on permanent section.

* NOTE: Patients with metastatic breast cancer identified by immunohistochemistry (IHC) are not eligible.
12. Patient randomized to ALND must undergo ALND within 42 days of their SLND.
13. A patient with a history of a previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided that the following criteria are met:

1. The patient has undergone potentially curative therapy for all prior malignancies,
2. There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in -situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), and
3. The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
14. Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
15. Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient is lactating (breastfeeding).
2. Patient has been previously treated with chemotherapy, estrogen receptor antagonists (i.e., Tamoxifen) or selective estrogen receptor modulators (SERMs, i.e., Raloxifene) for this invasive breast cancer.
3. Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
4. Patient has concurrent invasive bilateral breast malignancies.
5. Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
6. Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.
7. Patient has a medical contraindication to ALND or is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
8. Patient who is noted to have matted nodes or gross extranodal disease at the time of SLND.
9. Patient has three or more positive sentinel nodes by frozen section, touch prep, or H&E staining on permanent section.

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
1/04/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
605
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
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Florida
Country [9] 0 0
United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
State/province [20] 0 0
Minnesota
Country [21] 0 0
United States of America
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Mississippi
Country [22] 0 0
United States of America
State/province [22] 0 0
Missouri
Country [23] 0 0
United States of America
State/province [23] 0 0
New Hampshire
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
United States of America
State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
Rhode Island
Country [31] 0 0
United States of America
State/province [31] 0 0
South Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
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United States of America
State/province [34] 0 0
Utah
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United States of America
State/province [35] 0 0
Virginia
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United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
West Virginia
Country [38] 0 0
United States of America
State/province [38] 0 0
Wisconsin
Country [39] 0 0
Canada
State/province [39] 0 0
Manitoba
Country [40] 0 0
Ireland
State/province [40] 0 0
Cork
Country [41] 0 0
Ireland
State/province [41] 0 0
Dublin

Funding & Sponsors
Primary sponsor type
Other
Name
Alliance for Clinical Trials in Oncology
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Armando E. Giuliano, MD
Address 0 0
Saint John's Cancer Institute
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00003855