Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Lymph Node Mapping in Patients with Primary Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Diagnostic	Closed	Over 18	NCI	RPCI-DS-95-14 NCI-G97-1333

Objectives

I.  Determine whether injection of technetium Tc 99m sulfur colloid and 
isosulfan blue into breast parenchyma around breast cancer allows 
identification of axillary lymph nodes in breast cancer. 

II.  Determine the predictive value of technetium sulfur colloid sentinel 
node(s) identification in determining axillary lymph node involvement in 
breast cancer.

III.  Determine the predictive value of isosulfan blue sentinel node(s) 
identification in determining axillary lymph node involvement in breast cancer.

IV.  Determine the predictive value of combined technetium sulfur colloid and 
isosulfan blue sentinel node(s) identification in determining axillary lymph 
node involvement in breast cancer.

Entry Criteria

Disease Characteristics:

Histologically confirmed stage I or II breast cancer
 T1, T2, or T3
 Clinically positive or negative nodes

Undergoing breast cancer surgery

Planned surgery to include axillary lymph node dissection, which may be:
  Part of modified radical mastectomy
  In conjunction with lumpectomy of the primary tumor
  Reexcision of a previously excised tumor bed OR
  A separate procedure (where reexcision of a previous biopsy site is not
   necessary) 

No tumors involving skin or chest wall muscle or with clinical dermal
lymphatic involvement

Prior/Concurrent Therapy:

See Disease Characteristics

Patient Characteristics:

Age:
 Over 18

Sex:
 Female

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No medical contraindications to general anesthesia
 No evidence of breast infection
 No known allergies to technetium sulfur colloid
 No known allergies or hypersensitivity reactions to isosulfan blue or other
  triphenylmethane or related compounds 
 Not pregnant

Expected Enrollment

A minimum of 50 patients will be accrued into this study.  The total accrual 
cannot be determined because the success rate in identification of sentinel 
node(s) is not known.

Outline

Breast tissue surrounding the breast tumor or the prior biopsy site is 
injected with a mixture of isosulfan blue and technetium labeled sulfur 
colloid 60-90 minutes before induction of general anesthesia.  The operation 
of axillary mode dissection either alone or in combination with breast wide 
excision or mastectomy proceeds as usual as clinically planned.  Prior to 
making the skin incision in the axilla, a sterile sleeved hand held gamma 
probe is used to identify any regions of increased uptake in the axilla, and 
the skin is marked with a standard surgical marking pen.  Upon entering the 
axilla, nodes marked by concentration of radioactivity identified using gamma 
probe or by concentration of blue dye are removed separately and analyzed 
pathologically in separate cassettes.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Stephen Edge, MD, Protocol chair		Ph: 716-845-2918; 800-685-6825