Table 1.
Inclusion criteria |
---|
Confirmed presence of primary breast cancer |
Candidate for surgical intervention, with lymph node mapping being part of the surgical plan |
At least 18 years of age at time of consent |
ECOG performance status of grade 0–2 |
If female, either negative pregnancy test within 72 h prior to [99mTc]tilmanocept administration, having been surgically sterilized, or postmenopausal for at least 1 year prior to start of study |
Pure ductal carcinoma in situ (DCIS) or noninvasive carcinoma with lymph node biopsy as part of the surgical plan |
Exclusion criteria |
---|
Pregnancy or lactation |
Clinical or radiological evidence of metastatic cancer, including palpably abnormal or enlarged lymph nodes |
Known hypersensitivity to Lymphazurin or patent blue V |
Participation in another investigational drug study |
Bilateral primary breast cancers or multiple breast tumors |
Prior surgical breast surgery (e.g., axillary surgery, implants) |
Scheduling for bilateral mastectomy if bilateral SLN mapping is required |
Preoperative radiation therapy to the affected breast or axilla |