Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	NCI, Other	CDR0000066987 NSABP-B-32, NCT00003830

Trial Description

Summary

RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.

Further Study Information

OBJECTIVES:

• Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative.

• Compare the effect of these two regimens on the overall and disease-free survival of these patients.

• Compare the morbidity associated with these two regimens in these patients.

• Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology.

• Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology.

• Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons.

• Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients.

Objectives of quality of life questionnaire in sentinel node-negative patients:

• Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens.

• Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side.

• Compare the impact of arm edema, range of motion, and sensory neuropathy on self-assessed measures of daily functioning, symptoms, and overall quality of life of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to the surgical treatment plan (lumpectomy vs mastectomy), age (49 and under vs 50 and over), and clinical tumor size (no greater than 2.0 cm vs 2.1-4.0 cm vs at least 4.1 cm). Patients are randomized to one of two surgery arms.

All patients receive technetium (Tc 99m) sulfur colloid injected into normal breast tissue within 1 cm of the primary tumor or biopsy cavity and an intradermal injection of technetium (Tc 99m) sulfur colloid, approximately 0.5-8 hours before surgery. Patients also receive an injection of isosulfan blue dye around the tumor or biopsy cavity after a hot spot is identified with a gamma detector. If a hot spot is not identified, the blue dye is injected after a saline bolus injection.

• Arm I: Patients undergo sentinel node resection immediately followed by conventional axillary dissection.

• Arm II: Patients undergo sentinel node resection and an intraoperative examination of sentinel nodes.

Patients with positive sentinel nodes undergo axillary dissection after sentinel node resection.

Patients with cytologically negative sentinel nodes do not undergo axillary dissection.

Patients with cytologically negative but histologically positive sentinel nodes return to surgery for axillary dissection.

Patients with histologically positive sentinel nodes and those in whom the sentinel node is not identified undergo axillary dissection after sentinel node resection.

Patients with pathologically positive, nonaxillary sentinel nodes undergo axillary dissection after sentinel node resection.

Patients with evidence of tumor remaining after surgery undergo a total mastectomy.

Quality of life is assessed at baseline, at weeks 1-3, and then every 6 months for 3 years or until recurrence.

Patients are followed at 1 and 3 weeks, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 5,400 patients will be accrued for this study within 4 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following:

• Histologically confirmed by core or open biopsy

• Confirmed by fine needle aspiration cytology AND positive clinical breast examination and ultrasound or mammography

• Clinically negative lymph nodes

• No positive ipsilateral axillary lymph nodes

• No prior removal of ipsilateral axillary lymph nodes

• No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy

• No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude

• Tethering or dimpling of the skin or nipple inversion allowed

• No bilateral malignancy or mass in the opposite breast that is suspicious for malignancy, unless proven nonmalignant by biopsy

• No diffuse tumors or multiple malignant tumors in different quadrants of the breast

• No other prior breast malignancy except lobular carcinoma in situ

• No prior or concurrent breast implants

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• Not specified

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• At least 10 years (excluding diagnosis of cancer)

Hematopoietic:

• Not specified

Hepatic:

• No hepatic systemic disease

Renal:

• No renal systemic disease

Cardiovascular:

• No cardiovascular systemic disease

Other:

• No prior malignancy within past 5 years except:

• Effectively treated squamous cell or basal cell skin cancer

• Surgically treated carcinoma in situ of the cervix

• Surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast

• No concurrent psychiatric or addictive disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for this cancer

Chemotherapy:

• No prior chemotherapy for this cancer, including neoadjuvant chemotherapy

Endocrine therapy:

• No prior hormonal therapy for this cancer

Radiotherapy:

• No prior radiotherapy for this cancer

Surgery:

• See Disease Characteristics

• No prior breast reduction surgery

• Prior excisional biopsy or lumpectomy allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

National Surgical Adjuvant Breast and Bowel Project

David N. Krag

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003830
Information obtained from ClinicalTrials.gov on October 14, 2009

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