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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00003855
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
6/07/2016

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
Treatment: Surgery - axillary lymph node dissection
Treatment: Other - whole breast irradiation

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.


Treatment: Surgery: axillary lymph node dissection


Treatment: Other: whole breast irradiation


Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Other
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
Gender
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
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)
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
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Delaware
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District of Columbia
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United States of America
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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United States of America
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Wisconsin
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Canada
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Manitoba
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Ireland
State/province [40] 0 0
Cork
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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
RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have
spread from tumors in the breast.

PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in
the armpit in treating women who have stage I or stage IIA breast cancer.
Trial website
https://clinicaltrials.gov/show/NCT00003855
Trial related presentations / publications
Ainsworth RK, Kollias J, Le Blanc A, De Silva P. The clinical impact of the American College of Surgeons Oncology Group Z-0011 trial--results from the BreastSurgANZ National Breast Cancer Audit. Breast. 2013 Oct;22(5):733-5. doi: 10.1016/j.breast.2012.11.005. Epub 2013 Jan 2.
Gainer SM, Hunt KK, Beitsch P, Caudle AS, Mittendorf EA, Lucci A. Changing behavior in clinical practice in response to the ACOSOG Z0011 trial: a survey of the American Society of Breast Surgeons. Ann Surg Oncol. 2012 Oct;19(10):3152-8. doi: 10.1245/s10434-012-2523-z. Epub 2012 Jul 21.
Olson JA Jr, McCall LM, Beitsch P, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group Trials Z0010 and Z0011. Impact of immediate versus delayed axillary node dissection on surgical outcomes in breast cancer patients with positive sentinel nodes: results from American College of Surgeons Oncology Group Trials Z0010 and Z0011. J Clin Oncol. 2008 Jul 20;26(21):3530-5. doi: 10.1200/JCO.2007.15.5630.
Leitch AM, McCall L, Beitsch P, et al.: Factors influencing accrual to ACOSOG Z0011, a randomized phase III trial of axillary dissection vs. observation for sentinel node positive breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-601, 2006.
Public notes

Contacts
Principal investigator
Name 0 0
Armando E. Giuliano, MD
Address 0 0
John Wayne 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

Summary results
Other publications