Breast cancer breast tumour
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age * 18 years - Primary breast cancer, any T-stage, any N-stage - Invasive carcinoma of the breast - Tumour histology and receptor status established by pre-NST core biopsy - Neoadjuvant systemic therapy (with at least 1 regime of chemotherapy) - MRI performed prior to NST - MRI scan after NST showed radiologic complete or partial response (0.1 * 2.0 cm contrast enhancement, *30% decrease in tumor size, according to RECIST 1.1 criteria) on MRI* - Correct position of the marker at the center of the original tumour bed - Written and signed informed consent;* NB: When a patient showed radiologic complete response on MRI before the last course of NST and the patient does not wish to undergo an additional MRI after NST, the patient may be included in the MICRA trial. When a patient showed partial response on MRI before the last course of NST and the patient does not wish to undergo additional MRI after NST, the patient may NOT be included in the MICRA trial.
Exclusion criteria
Exclusion criteria: - Contra-indications for MR imaging - Ductal carcinoma in situ as shown by core biopsy pre-NST - Distant metastatic disease - Prior radiotherapy or surgery of the ipsilateral breast
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is specificity of post-NST biopsies of the breast in assessing the presence of pCR after NST. Secondary endpoints are the false-negative rate, negative and positive predictive value and sensitivity of the biopsies. | — |
Secondary
| Measure | Time frame |
|---|---|
| - A secondary endpoint is to identify patient groups in which presence or absence of a pathologic complete response can be reliably predicted following neoadjuvant chemotherapy by imaging methods and/or post-NAC biopsies. - Another secondary endpoint is to evaluate how many biopsies would be required to correctly assess the presence of a pathologic complete response. | — |
Countries
Netherlands
Outcome results
None listed