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Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer



Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer

For Condition: stage 2 breast cancer,stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): Royal Marsden NHS Trust ,
Synopsis: RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease. PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer.
Details: OBJECTIVES: - Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in patients with resectable stage I or II breast cancer. OUTLINE: Patients are stratified according to node status (positive vs negative). Patients undergo lymphoscintigraphy, which consists of technetium Tc 99m human serum albumin colloid being injected near the tumor. Dynamic imaging using a gamma camera is performed for 20 minutes postinjection and static images are obtained for up to 3 hours postinjection. Surgery is performed within 24 hours of lymphoscintigraphy. Patients are injected with patent blue V dye near the tumor and a gamma detection probe is used to measure radioactive counts in the sentinel node. Surgery begins within 5 minutes of the patent blue V dye injection. All lymph nodes that stain blue or have a high radioactive count are removed. The primary breast lump is removed by either wide local excision or mastectomy and the axilla are cleared by standard axillary dissection. Some patients may only receive patent blue V dye injected as a pilot study. Sentinel lymph node biopsy and axillary dissection proceed as above. PROJECTED ACCRUAL: A total of 150 patients (75 per stratum) will be accrued for the main study plus another 50 patients for the pilot study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage I or II invasive breast cancer by triple assessment: - Clinically - Mammogram and/or ultrasound - Fine needle cytology - Resectable disease by either wide local excision or mastectomy with axillary dissection - No ductal carcinoma in situ - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant - No known allergy to vital blue dye - No mental illness or handicap that would preclude study entry - No other severe illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GeraldGui,  Study Chair,  Royal Marsden NHS Trust

Royal Marsden Hospital
Sutton,  England,  SM2 5PT
United Kingdom
 

St. George's Hospital
London,  England,  SW17 0QT
United Kingdom
 

Royal Marsden NHS Trust
London,  England,  SW3 6JJ
United Kingdom
 

Royal Brompton National, Heart and Lung Hospital
London,  England,  SW3 6NP
United Kingdom
 


Additional Information:
Study ID Numbers:
  CDR0000067828;  RMNHS-1631,EU-20006
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005821

Other Stage 1 Breast Cancer Studies:
1. Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed

2. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer

3. Trastuzumab in Treating Women With Breast Cancer

4. Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer

5. Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

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Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer

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