Statement: Patients with pure ductal carcinoma in situ (DCIS) are eligible for both the secondary trial and the primary trial.
Primary_evidence: Inclusion Criteria:   The patient has provided written informed consent with HIPAA authorization before participating in the study, as has his/her responsible caregiver, if applicable.   The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.   The patient is at least 18 years of age at the time of consent.   The patient has an ECOG performance status of Grade 0 - 2 [8].   The patient has a clinical negative node status at the time of study entry.   If of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.   The patient is currently not participating in another investigational drug study.   Melanoma Patients   The patient has a diagnosis of primary melanoma.   Breast Cancer Patients   The patient has a diagnosis of primary breast cancer.   Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan. Exclusion Criteria:   The patient is pregnant or lactating;   The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0);   The patient has a known hypersensitivity to Lymphazurin or Patent Bleu V.   Melanoma Patients   The patient has a tumor with a Breslow depth less than 0.75mm.;   Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy;   Patients diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin;   Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma;   Patients who have undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap or skin graft of any type).   Breast Cancer Patients   The patient has bilateral primary breast cancers or multiple tumors within their breast;   Patients that have had prior surgical procedures such as breast implants, reduction mammoplasty or axillary surgery;   Patients scheduled for bilateral mastectomy for any reason;   Patients that have had preoperative radiation therapy to the affected breast or axilla
Secondary_evidence: Inclusion Criteria:   Female, 18-100 years old   Not pregnant or breastfeeding   Pre-study radiologic documentation of:   size  5 cm   unicentric, unilateral   suspicious mass or calcification   BIRADS classification  IV   location of abnormality > 1 cm from skin   Ductal or Infiltrating Ductal Carcinoma   Grade I-III on final pathology   Good general health   Zubrod Performance Status of 0,1, or 2   No previous chemotherapy   No palpable axillary or supraclavicular lymph nodes   If prior non-breast malignancy, must have > 5 year disease-free survival Exclusion Criteria:   Patient < 18 y/o or > 100 y/o   Pregnant or breastfeeding   Male   Breast implants   Multicentric disease or bilateral disease   Lesions > 5 cm in diameter   Lesions < 1.0 cm from the skin   Previous prior radiation to the breast   Need for mastectomy   Diffuse microcalcifications (as determined by the Investigator)