|- candidate number||25494|
|- NTR Number||NTR6120|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-nov-2016|
|- Secondary IDs||N16MIC (local study ID number) |
|- Public Title||Towards omitting breast cancer surgery in patients without residual tumor after upfront chemotherapy. |
|- Scientific Title||MICRA study: Minimally Invasive Complete Response Assessment of the breast after primary systemic treatment|
|- hypothesis||We hypothesize that in breast cancer patients with radiologic complete response (rCR) on MRI after primary systemic treatment (PST), a pathologic complete response (pCR) can reliably be predicted with use of multiple biopsies after PST. |
|- Healt Condition(s) or Problem(s) studied||Mamma carcinoma, Neoadjuvant chemotherapy, Surgery|
|- 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||- Contra-indications for MR imaging|
- Ductal carcinoma in situ associated with microcalcifications as shown by core biopsy
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||5-apr-2016|
|- planned closingdate||5-apr-2019|
|- Target number of participants||440|
|- 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 completion of PST, a MRI is performed to evaluate radiologic response. In patients with a radiologic complete response, eight biopsies of the original tumor bed are obtained, just before surgery when patients are under general anaesthesia (to minimize patient discomfort). The biopsies are obtained with use of a 14-gauge core needle. Four biopsies are obtained at <0.5 cm distance of the marker and 4 biopsies are obtained at 1.0-1.5 cm distance of the marker. Immediately after collection of the biopsies, conventional surgery is performed, which may consist of breast conserving surgery or mastectomy.
Pathology results of the biopsies and resected specimens are compared, to assess whether pCR can be reliably determined on post-PST biopsies. |
|- Primary outcome||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 outcome||To evaluate how many biopsies would be required to correctly assess the presence of a pCR.|
|- Timepoints||4-2016: MEC approval|
4-2016: Start patient accrual
12-2016: Submit pilot and study design for publication
4-2017: Start designing national registration study
12-2017: Interim analysis and report
4-2019: Finish patient accrual
4-2019: Submit study results for publication
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.T.F.D. Vrancken Peeters|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.T.F.D. Vrancken Peeters|
|- Sponsor/Initiator ||Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) , Isala Clinics Zwolle, University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Improvements in PST for breast cancer patients have led to increasing rates of pCR. However, until now no imaging modalities (or techniques) have been described to reliably identify patients with a pCR of the breast. Therefore, many patients still encounter overtreatment since patients undergo surgery of the original tumour area to confirm the absence or presence of pCR after PST.
The ultimate aim of our study is to eliminate surgical treatment in breast cancer patients achieving pCR after PST, thus preventing overtreatment and improving quality of life. We will achieve this aim by identifying patients with pCR following PST without surgical removal of (part of the) breast.
We will assess the value of biopsies of the breast in determining pathologic response to PST, in patients with rCR on MRI.
The MICRA trial is a 3 year observational prospective cohort study. Patients included are patients who are diagnosed with invasive breast cancer and showed rCR on MRI after PST.
In these patients, eight ultrasound-guided core biopsies (14G needle) are performed at the site of the original tumour bed, which is marked with before PST (with a iodine seed, clip or hydro marker). Immediately hereafter, breast surgery is performed. Pathology results of biopsies and surgical specimens are compared, to determine the accuracy of this diagnostic procedure. Results from these biopsies will be combined with data on imaging, patient and tumour characteristics.
For treatment of the breast these results will define 2 patient groups:
- Presence of residual disease can be reliably predicted on MRI without obtaining post-PST pathology
- Presence/absence of pCR needs to be assessed by biopsies, and surgery may be omitted if biopsies show no residual tumour
|- Main changes (audit trail)|
|- RECORD||2-nov-2016 - 11-dec-2016|