Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer

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ClinicalTrials.gov Identifier: NCT00003855

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : July 6, 2016

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

Tracking Information

First Submitted Date ^ICMJE

November 1, 1999

First Posted Date ^ICMJE

January 27, 2003

Last Update Posted Date

July 6, 2016

Study Start Date ^ICMJE

April 1999

Actual Primary Completion Date

August 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall survival [ Time Frame: Up to 10 years ]
Morbidity [ Time Frame: Up to 10 years ]
Disease-free survival [ Time Frame: Up to 10 years ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003855 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer

Official Title ^ICMJE

A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node

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.

Detailed Description

OBJECTIVES:

Primary objectives:

Long term: To assess whether overall survival for patients randomized to Arm 2 (no immediate ALND) is essentially equivalent to (or better than) than that for patients assigned to Arm 1 (completion ALND).

Short term: To quantify and compare the surgical morbidities associated with SLND plus ALND versus SLND alone.

OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: axillary lymph node dissection
Radiation: whole breast irradiation

Study Arms

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.
Interventions:
- Procedure: axillary lymph node dissection
- Radiation: whole breast irradiation
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.

Intervention: Radiation: whole breast irradiation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

605

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date

February 2011

Actual Primary Completion Date

August 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Patient must be female.
Patient must be at least 18 years of age.
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.
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.
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.
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.
Patient must have ECOG/Zubrod status =2, as documented in patient's medical record.
Patient must be available for follow-up.
Patient of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
Patient must have access to radiation therapy.
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.
Patient randomized to ALND must undergo ALND within 42 days of their SLND.
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.
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.
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.

Exclusion Criteria:

Patient is lactating (breastfeeding).
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.
Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
Patient has concurrent invasive bilateral breast malignancies.
Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.
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.
Patient who is noted to have matted nodes or gross extranodal disease at the time of SLND.
Patient has three or more positive sentinel nodes by frozen section, touch prep, or H&E staining on permanent section.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Canada, Ireland, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00003855

Other Study ID Numbers ^ICMJE

ACOSOG-Z0011
GUMC-00153
CDR0000067018 ( Registry Identifier: NCI Physician Data Query )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Alliance for Clinical Trials in Oncology

Study Sponsor ^ICMJE

Alliance for Clinical Trials in Oncology

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Armando E. Giuliano, MD

John Wayne Cancer Institute

PRS Account

Alliance for Clinical Trials in Oncology

Verification Date

July 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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