Invasive mammacarcinoma / malignant breast tumour
Conditions
Interventions
US-guided surgery (USS).
(Control: Traditional palpation-guided surgery (PGS)).
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women age 25-75 yrs who are diagnosed with palpable early-stage (T1-2N0-1) primary breast cancer in the trial centres. Breast cancer will be diagnosed with physical examination, mammography (2R) and US of the breast and axilla. The diagnosis of invasive (ductal or lobular) breast cancer will be established with image-guided core needle biopsy or cytological puncture. All patients will be suitable for BCT according to national guidelines. Participants will not have a history of prior mammary surgery in the affected breast, radiation therapy or neo-adjuvant therapy. Participants will have ASA Classification I - III and will be well-informed having signed an informed consent form.
Exclusion criteria
Exclusion criteria: Participants with a history of prior mamma surgery, radiation therapy or neo-adjuvant therapy. Patients younger than 25 years, patients age above 75 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameters are the volume of resected breast tissue excised (compared to the optimal resected volume) and the oncological margin status. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are cosmetic outcomes and quality of life. | — |
Countries
Netherlands
Outcome results
None listed