OBJECTIVES:

1. Compare the long-term control of regional disease by sentinal node resection vs sentinal node resection followed by conventional axillary dissection in women with breast cancer who are clinically node-negative and pathologically sentinal node-negative.
2. Compare the effect of these two regimens on the overall and disease-free survival of these patients.
3. Compare the morbidity associated with these two regimens in these patients.
4. Compare the prognostic value of these two regimens in patients who are sentinal node-negative or positive by pathology.
5. Determine the potentially increased risk of systemic recurrence in patients who are node-negative by pathology.
6. Determine the technical success rate of sentinal node dissection and the variability of technical success rate in a broad population of surgeons.
7. Determine the sensitivity of the sentinal node to determine the presence of nodal metastases in these patients.
   

PARTICIPATION CRITERIA:

• Resectable invasive adenocarcinoma of the breast
• 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 breast implants

STUDY CONTACT
David N. Krag, Chair, Ph: 802-656-5830
National Surgical Adjuvant Breast and Bowel Project
Pittsburgh, Pennsylvania

OBJECTIVES:

1. Determine local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, overall survival and toxicity of breast surgery with vs without axillary node dissection in elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen.
2. Compare the quality of life in patients treated with the two regimens.

PARTICIPATION CRITERIA:

• Age: 60 and over
• Postmenopausal
• Histologically or cytologically diagnosed stage I or IIA breast carcinoma that is considered operable
• No prior axillary clearance or biopsy allowed
• Complete excisional biopsy without axillary clearance or biopsy allowed

STUDY CONTACT
Diana Crivellari, Chair, Ph: 39-434-659206
International Breast Cancer Study Group
Centro di Riferimento Oncologico - Aviano
Aviano, Italy

OBJECTIVES:

1. Assess the efficacy of quadrantectomy vs quadrantectomy with axillary lymph node dissection followed by tamoxifen in patients with stage I breast cancer, with efficacy measured by local and distant relapse rates and by overall survival.
2. Study the relationship between biological variables, such as hormone receptor status, cell proliferation and DNA ploidy, and the clinical outcome of the disease.

PARTICIPATION CRITERIA

• Age range: 65 to 80
• Postmenopausal
• Histologically confirmed invasive breast cancer
• Clinical stage I (T1, N0, M0)
• Hormone receptor status:
  Estrogen receptor-positive
  Progesterone receptor-positive or -negative

STUDY CONTACT
Gabriele Martelli, Ph: 39-2-2390-324
Chemo Prevention Unit
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), Italy

OBJECTIVES:

I. Compare high vacuum drainage vs low vacuum drainage vs simple tube drainage in patients undergoing axillary surgery for stage I or II breast cancer.

PARTICIPATION CRITERIA

• Diagnosis of resectable stage I or II breast cancer
• Planned primary surgery of level II or III axillary dissection in association with one of the following:
  - Wide local excision (may be done through separate incision)
  - No breast surgery
  - No immediate breast reconstruction using implants, latissimus dorsi or rectus abdominus myocutaneous flaps at primary operation
• No prior Mastectomy
• No prior axillary surgery

STUDY CONTACTS
Gerald Gui, Chair, Ph: +44-20-7808-2783
Royal Marsden NHS Trust
London, England, United Kingdom

Anthony G. Nash, Ph: 0181-642-6011
Royal Marsden Hospital
Sutton, England, United Kingdom

N.P.M. Sacks, Ph: 171-3-52-81-71
Royal Marsden NHS Trust
London, England, United Kingdom

OBJECTIVES:

1. Compare sentinel node biopsy vs axillary dissection in determining axillary nodal status in patients with resectable stage I or II breast cancer.

PARTICIPATION CRITERIA

• Diagnosis of stage I or II invasive breast cancer by triple assessment (clinical, mammogram and/or ultrasound, FNA)
• Resectable disease by either wide local excision or mastectomy with axillary dissection

PROTOCOL
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.

STUDY CONTACT
Gerald Gui, Chair, Ph: +44-20-7808-2783
Royal Marsden NHS Trust
London, England, United Kingdom

OBJECTIVES:

1. 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.
2. Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry for the first 3,600 women in this patient population.
3. Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H&E) staining.
4. 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.

PARTICIPATION CRITERIA

• Histologically or cytologically confirmed stage I or IIA (T1 or T2 N0 M0) breast carcinoma diagnosed within 60 days of planned sentinel lymph node dissection • Tumor must not be attached to the skin, underlying muscle or chest wall
• No contralateral, supraclavicular or infraclavicular node involvement
• No bilateral breast malignancies and no more than 1 malignant tumor mass present in the same breast • Tumor must be amenable to segmental mastectomy (lumpectomy)
• Medial quadrant lesions must have axillary drainage demonstrated
• Surgery: No prior ipsilateral axillary surgery, excisional biopsy cavity exceeding 6 cm in diameter or prepectoral breast implant

STUDY CONTACT:
Armando E Giuliano, Chair Ph: 310-829-8089
American College of Surgeons Oncology Group

OBJECTIVES:

1. Determine whether axillary lymph node dissection (ALND) improves overall survival in patients with stage I or IIA breast cancer.
2. Quantify and compare surgical morbidities associated with sentinel lymph node dissection with or without ALND in these patients.

PARTICIPATION CRITERIA

• No matted lymph nodes or gross extranodal disease
• Sentinel node must have been identified and found to contain metastatic disease
• Histologically or cytologically confirmed stage I or IIA breast carcinoma amenable to lumpectomy
• Tumor must not have been attached to the skin, underlying muscle or chest wall
• No bilateral breast malignancies, and no more than 1 malignant tumor mass present in the same breast
• No more than 2 positive lymph nodes
• Lumpectomy margins must be free of disease
• Surgery: No prepectoral implant; no prior ipsilateral axillary surgery

STUDY CONTACT
Armando E Giuliano, Ph: 310-829-8089
John Wayne Cancer Institute
Santa Monica, California