Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003854
• Other study ID #: ACOSOG-Z0010
• Secondary ID: GUMC-00152CDR000
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: April 1999
• Est. completion date: July 2011

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer.

PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.

Description:

OBJECTIVES:

• Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer.

• Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients.

• Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H&E) staining.

• Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H&E so that these women can be considered as candidates for ACOSOG-Z0011.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4590
• Est. completion date: July 2011
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be female.

2. Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be amenable to segmental mastectomy (lumpectomy).

3. 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.

4. The date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of breast carcinoma must be no more than 60 days prior to SLND.

5. The patient who had segmental mastectomy (lumpectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the lumpectomy was less than or equal to 60 days prior to the SLND. Copies of the operative and pathology reports must be submitted as a part of the registration process.

6. Patient must have ECOG/Zubrod status of =2, as documented in patient's medical record.

7. Patient must be available for follow-up.

8. The 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.

9. Signed and dated informed consent is obtained prior to patient registration.

10. Patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.

11. Patient must be able to physically undergo bilateral anterior iliac crest bone marrow aspiration.

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 is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.), which would preclude the treatment options.

5. Patient has concurrent bilateral invasive breast malignancies.

6. Patient is not able to undergo and does not have access to radiation therapy as describedin Adjuvant Radiation Therapy in the Interventions section of the protocol.

Patients with active connective tissue disorders and those that live too far from a radiation treatment center, for example, would not be eligible.

7. Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.

8. Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• immunohistochemistry staining method

Procedure:
• lymphangiography

• sentinel lymph node biopsy

• therapeutic conventional surgery

Radiation:
• whole breast irradiation

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Institute	East Melbourne	Victoria
Ireland	Cork University Hospital	Cork
Ireland	St. Vincent's University Hospital	Dublin
United States	Sacred Heart Hospital	Allentown	Pennsylvania
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Texas Cancer Center at Brackenridge Hospital	Austin	Texas
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Belleville Memorial Hospital	Belleville	Illinois
United States	St. Elizabeth's Hospital	Belleville	Illinois
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	St. Luke's Regional Medical Center	Boise	Idaho
United States	Lutheran Medical Center	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Lahey Clinic - Burlington	Burlington	Massachusetts
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Northwestern University Medical Center	Chicago	Illinois
United States	Carilion New River Valley Medical Center	Christiansburg	Virginia
United States	Tri-Health Good Samaritan Hospital	Cincinnati	Ohio
United States	Morton Plant Mease Health Care	Clearwater	Florida
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Memorial Hospital Cancer Center	Colorado Springs	Colorado
United States	Columbia Regional Hospital	Columbia	Missouri
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	University of Missouri-Columbia Hospital and Clinics	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	St. Paul University Hospital	Dallas	Texas
United States	Zale Lipshy University Hospital	Dallas	Texas
United States	DeKalb Medical Center, Inc.	Decatur	Georgia
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Durham Regional Hospital	Durham	North Carolina
United States	CCOP - Evanston	Evanston	Illinois
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Little Company of Mary Hospital - Evergreen Park	Evergreen Park	Illinois
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	McLaren Regional Cancer Center	Flint	Michigan
United States	University of Texas Medical Branch	Galveston	Texas
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Spectrum Health - Butterworth Campus	Grand Rapids	Michigan
United States	Kaiser Permanente Medical Center	Honolulu	Hawaii
United States	St. Francis Medical Center	Honolulu	Hawaii
United States	Ben Taub General Hospital	Houston	Texas
United States	Methodist Hospital	Houston	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	Benedictine Hospital	Kingston	New York
United States	Kingston Hospital	Kingston	New York
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Watson Clinic	Lakeland	Florida
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Baptist Health Medical Center	Little Rock	Arkansas
United States	St. Vincent Doctors Doctors Hospital	Little Rock	Arkansas
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Norton Healthcare System	Louisville	Kentucky
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Saint Anthony Memorial Health Center - Michigan City Campus	Michigan City	Indiana
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Providence Hospital - Mobile AL	Mobile	Alabama
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Mount Holly	New Jersey
United States	Baptist Hospital	Nashville	Tennessee
United States	Sarah Cannon-Minnie Pearl Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	St. Luke's-Roosevelt Hospital Center - Roosevelt Division	New York	New York
United States	Summit Medical Center	Oakland	California
United States	St. Joseph Hospital - Orange	Orange	California
United States	Huntington Memorial Hospital	Pasadena	California
United States	Singing River Hospital	Pascagoula	Mississippi
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mercy Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Women and Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Carilion Health System - Cancer Center of Western Virginia	Roanoke	Virginia
United States	Highland Hospital of Rochester	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California Davis Cancer Center	Sacramento	California
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Bayfront Medical Center	Saint Petersburg	Florida
United States	Columbia Lewis-Gale Medical Center	Salem	Virginia
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Latter Day Saints Hospital	Salt Lake City	Utah
United States	Donald N. Sharp Memorial Community Hospital	San Diego	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	Lester E. Cox Medical Centers	Springfield	Missouri
United States	Park Nicollet Clinic	St. Louis Park	Minnesota
United States	Martin Memorial Cancer Medical Center	Stuart	Florida
United States	Tallahassee Memorial Healthcare	Tallahassee	Florida
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Kent County Memorial Hospital	Warwick	Rhode Island
United States	Lombardi Cancer Center	Washington	District of Columbia
United States	Henry Ford Medical Center - West Bloomfield	West Bloomfield	Michigan
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
United States	York Cancer Center	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Ireland, 

References & Publications (7)

Giuliano AE, Hawes D, Ballman KV, Whitworth PW, Blumencranz PW, Reintgen DS, Morrow M, Leitch AM, Hunt KK, McCall LM, Abati A, Cote R. Association of occult metastases in sentinel lymph nodes and bone marrow with survival among women with early-stage inva — View Citation

Hunt KK, Ballman KV, McCall LM, Boughey JC, Mittendorf EA, Cox CE, Whitworth PW, Beitsch PD, Leitch AM, Buchholz TA, Morrow MA, Giuliano AE. Factors associated with local-regional recurrence after a negative sentinel node dissection: results of the ACOSOG — View Citation

Leitch AM, Beitsch PD, McCall LM, Posther K, Newman LA, Herndon JE 2nd, Hunt KK, Giuliano AE. Patterns of participation and successful patient recruitment to American College of Surgeons Oncology Group Z0010, a phase II trial for patients with early-stage — View Citation

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. — View Citation

Posther KE, McCall LM, Blumencranz PW, Burak WE Jr, Beitsch PD, Hansen NM, Morrow M, Wilke LG, Herndon JE 2nd, Hunt KK, Giuliano AE. Sentinel node skills verification and surgeon performance: data from a multicenter clinical trial for early-stage breast c — View Citation

Wilke LG, Ballman KV, McCall LM, Giuliano AE, Whitworth PW, Blumencranz PW, Reintgen DS, Burak WE, Leitch AM, Hunt KK. Adherence to the National Quality Forum (NQF) breast cancer measures within cancer clinical trials: a review from ACOSOG Z0010. Ann Surg — View Citation

Wilke LG, McCall LM, Posther KE, Whitworth PW, Reintgen DS, Leitch AM, Gabram SG, Lucci A, Cox CE, Hunt KK, Herndon JE 2nd, Giuliano AE. Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperativ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Up to 10 years	No
Secondary	Disease-free survival		Up to 10 years	No
Secondary	Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND		Up to 10 years	No