Trial Information

A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients

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.