Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: axillary lymph node dissection Radiation: whole breast irradiation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
| Estimated Enrollment: | 1900 |
| Study Start Date: | April 1999 |
OBJECTIVES:
- Determine whether axillary lymph node dissection (ALND) improves overall survival in women with stage I or IIA breast cancer.
- Quantify and compare surgical morbidities associated with sentinel lymph node dissection with or without ALND in these patients.
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.
- Arm I: 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.
- Arm II: Patients undergo breast radiotherapy only as in arm I. Patients in both arms 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.
PROJECTED ACCRUAL: Approximately 1,900 patients (950 per treatment arm) will be accrued for this study within 3.8 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage I or IIA (T1 or T2, N0, M0) invasive breast carcinoma amenable to lumpectomy
- Tumor must be less than 5 cm
- No palpable nodes
- No evidence of metastatic disease
- Cytologic diagnosis suggestive of carcinoma from a fine-needle aspiration from a palpable or nonpalpable breast lesion and clinically suspicious for invasive breast carcinoma allowed
- No concurrent bilateral breast malignancies
- Diagnosis no more than 60 days prior to sentinel lymph node dissection (SLND)
- Sentinel node must have been identified and found to contain metastatic disease
- No matted lymph nodes or gross extranodal disease
- No more than 2 positive sentinel nodes
- No clinically or radiologically identified multifocal disease not amenable to a single lumpectomy
Hormone receptor status:
- Estrogen receptor positive or negative
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG (Zubrod) 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Must not be considered a poor surgical risk due to any other nonmalignant systemic disease
- No other prior malignancies within the past 5 years except successfully treated basal cell or squamous cell skin cancer or surgically treated carcinoma in situ of the cervix or lobular carcinoma in situ of the ipsilateral or contralateral breast
- All prior malignancies must have been curatively treated and risk of recurrence must be low
- Not pregnant or nursing
- Negative pregnancy test
- No other medical condition contraindicating axillary lymph node dissection or postoperative breast radiotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for this breast cancer
Endocrine therapy:
- No prior estrogen receptor antagonist (i.e., tamoxifen) or selective estrogen receptor modulators therapy (i.e., raloxifene) for this breast cancer
Radiotherapy:
- Not specified
Surgery:
- Prior breast-conserving therapy (i.e., segmental mastectomy) allowed if no more than 60 days prior to SLND
No pre-pectoral breast implant
- Subpectoral implant allowed
- No prior ipsilateral axillary surgery (e.g., excisional biopsy of the lymph nodes or treatment of hidradenitis)
Contacts and Locations
Show 156 Study Locations| Study Chair: | Armando E. Giuliano, MD | John Wayne Cancer Institute at Saint John's Health Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003855 History of Changes |
| Other Study ID Numbers: | CDR0000067018, ACOSOG-Z0011, GUMC-00153 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IA breast cancer stage IB breast cancer stage II breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013