Radiotherapy After Primary CHEMotherapy for cT1-2pN+M0 breast cancer.: a multicentre prospective cohort study.
Indication
Locoregional, Observational
Subindication
Not applicable
Target sample size
860
Actual accrual
850
Date: 01/02/2016
Estimated study completion date
01/01/2021
Contact
Sponsor
BOOG
Principal Investigator(s)
L.J. Boersma, A. Voogd, P. Elkhuizen
Study manager
A.E. van Leeuwen-Stok
Central datamanagement and randomization
n.v.t.
Monitoring
n.v.t.
Local datamanagement
NKR
Funding
Funding by KWF
Design
Data registration study
Objectives
The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2pN+(excluding ≥cN2) breast cancer patients, treated with neo-adjuvant chemotherapy, breast surgery, and radiotherapy that is protocolised based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage). The secondary aim is to develop a risk model based on risk factors, that can be used to predict which of the patients with a cT1-2pN+(excluding ≥cN2) breast carcinoma, treated with neoadjuvant chemotherapy and surgery, have a 5 yr LRR > 8 % if radiotherapy is withheld.
Endpoints
Primary endpoint:
5 yr locoregional recurrence rate
Secondary endpoints:
10 year LRR, and 5, 10, and 15 yr overall survival rate
Correlation pre-radiotherapy factors (e.g. like age < 40 yr, response to chemotherapy, tumor size) with a high LRR
Eligibility Criteria
cT1-2pN+(excluding >=cN2) and at least three cycles of neoadjuvant chemotherapy followed by breast and axillary surgery