Breast cancer
Conditions
Interventions
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women, aged = 18 yearsInvasive HR positive/Her2 negative, Her2+ (ER/PR +/-) or TN breast cancerPrimary tumour (T) clinical stage cT1-2Unifocal disease; confirmed by pre-NST MRI, contrast-enhanced mammography or breast-specific gamma imagingClinical nodal stage 0; absence of lymph node metastases should be confirmed by ultrasound or FDG-PET/CTNeoadjuvant systemic treatment (NST)Marker placed in breast tumour prior to NSTBreast conserving surgery performed, i.e. no mastectomySentinel node biopsy performed before or after NSTPathologic complete response in breast and lymph nodes, i.e. no residual tumour cells, DCIS or LCIS detectedWritten informed consent within 16 weeks following the date of surgery
Exclusion criteria
Exclusion criteria: Primary tumour (T) clinical stage cT3-4Pre- or post-NST diagnosis of nodal disease including isolated tumour cellsConcurrent LCIS of any type in either pre-NST biopsy or surgical specimenPatients without axillary ultrasound or FDG-PET/CT pre-NSTHistory of breast cancer, DCIS or LCISSynchronous contralateral breast cancer, DCIS or LCISSynchronous M1 diseaseCarrier of gene mutation associated with increased risk of breast cancer, i.e. BRCA1, BRCA2, CHEK2, TP53 or PALB-2Concurrent DCIS in pre-NST biopsy with suspicion of extensive component i.e. absence of non-mass enhancement on pre-NST MRI, contrast-enhanced mammography or breast-specific gamma imaging and/or absence of calcifications on pre-NST mammographyHistory of or concurrent malignancy, except for adequately treated non-melanoma skin cancer or other cancers curatively treated with no evidence of disease for = 5 years.Ipsilateral non-mass enhancement on MRI and/or suspect calcifications on mammography not proven to be benign by biopsy prior to NST
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the local recurrence rate (LRR) at 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary determinants are Local non-salvageable recurrence free survivalQuality of lifeRegional recurrence rateDistant recurrence free survivalDisease-specific survivalOverall survival. | — |
Countries
Netherlands
Contacts
Public ContactF.H. Duijnhoven
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed