breast cancer breast neoplasms
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting with multiple invasive tumors in one or more quadrants of the breast. The minimal distance between two different invasive foci must be two centimeters. The minimal diameter of an invasive focus (of one tumor) must be one centimeter.
Exclusion criteria
Exclusion criteria: The maximum diameter of an invasive focus (one tumor) must be five centimeters. The maximum number of present invasive foci in one breast must be three tumors. Evidence of other breast-cancer related disease such as palpable or ultrasound detected lymph node metastases or distant metastases. Exclusive presence of ductal carcinoma in situ (DCIS). Incapacity or unwillingness of participant to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of sentinel nodes after first injection 2. Extra number of sentinel nodes after second injection 3. Different locations of sentinel nodes after first injection 4. Extra locations of sentinel nodes after second injection 5. Analysis of the possible differences in lymphatic drainage between patients with multifocal and multicentric tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lymph node recurrences 2. Overall and disease-free survival | — |
Countries
Netherlands