Statement: Patients with pure ductal carcinoma in situ (DCIS) or Melanoma are eligible for both the secondary trial and the primary trial, and are able to participate in these trials alongside other drug trials, up to a maximum of 3.
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)