English: breast cancer, neoadjuvant systemic therapy, primary systemic treatment, MRI, pathologic complete response, biopsy, response assessment Dutch: mammacarcinoom, neoadjuvante systemische therapie, neoadjuvante chemotherapie, MRI, pathologisch complete respons, biopt, responsevaluatie
Conditions
Interventions
In all patients receiving PST, a marker is placed at the center of the tumor area before the start of PST. Adequate position of the marker is confirmed by mammography and/or ultrasound.
After complet
Sponsors
Netherlands Cancer Institute
Isala Hospital
University Medical Center Utrecht
(more centers will join)
Eligibility
Inclusion criteria
Inclusion criteria: - Age > 18 year - Carcinoma of the breast - Treatment with primary systemic treatment - Tumour histology and receptor status established by pre-treatment core biopsy - Suitable for response evaluation with MRI - MRI scan after neoadjuvant systemic treatment showed complete radiologic response - Placement of marker (clip, hydro marker, iodine seed) at the center of the original tumour bed
Exclusion criteria
Exclusion criteria: - Contra-indications for MR imaging - Ductal carcinoma in situ associated with microcalcifications as shown by core biopsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the value of multiple biopsies of the breast in determining pathologic response to primary systemic treatment. We will therefore calculate the sensitivity, specificity, positive predictive value and negative predictive value of post-PST biopsies of the breast. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate how many biopsies would be required to correctly assess the presence of a pCR. | — |
Contacts
Public ContactM.T.F.D. Vrancken Peeters
Outcome results
None listed