breast cancer, breast carcinoma breast cancer
Conditions
Interventions
Single dose preoperative radiotherapy of 20 Gy to the tumor
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: WHO performance scale = 2Females at least 50 years of age with an ipsilateral invasive breast cancer event (i.e. recurrence, second primary) after previous breast conserving surgery and radiotherapy (for invasive breast cancer/carcinoma in situ)Tumor characteristics:Tumor size = 2 cm, unifocal on MRIOn tumor biopsy:Bloom-Richardson grade 1 or 2,non-lobular invasive histological type carcinoma,accompanying (non-extensive) DCIS is accepted within the tumor size of 2 cm on mammography and/or tumor biopsy, including no non-mass enhancement on MRI,ER-positive and HER2-negative tumor,No lymphovascular invasion.Clinical node negative on PET-CT, ultrasound and MRINo distant metastasesRepeat breast-conserving surgery is feasible, if no or mild late toxicity (no grade 2 or higher) from previous breast-conserving therapyAdequate communication and understanding skills of the Dutch languageWritten informed consent
Exclusion criteria
Exclusion criteria: Ipsilateral invasive breast cancer recurrence less than 2 years after first breast conserving therapy for breast cancer or ductal carcinoma in situLegal incapacityKnown breast cancer mutation gene carrierPrevious ipsilateral mastectomyCollagen synthesis disease (e.g. Osteogeneis imperfecta, Ehlers-Danlos syndrome, systemic lupus erythematosus)Invasive lobular carcinomaMRI absolute contraindications as defined by the Department of RadiologyIndication for treatment with neoadjuvant chemotherapyNon-feasible dosimetric RT planBreast implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of grade >= 2 acute radiation-induced toxicity within 3 months followingpreoperative radiotherapy and postoperative complications within 30 days using Common Terminology Criteria for Adverse Events v.5.0 (skin toxicity, breast edema, breast pain and chest wall pain) and the Clavien-Dindo Classification (wound infection) | — |
Secondary
| Measure | Time frame |
|---|---|
| Other acute and late radiotherapy- and surgery-associated toxicity, mastectomy rates, quality of life, cosmetic outcomes, patient satisfaction, local recurrence, regional recurrence, distant metastases, disease-free survival, breast cancer specific- and overall survival rates, radiologic and pathologic response. | — |
Countries
Netherlands
Contacts
Public ContactL.F. Wurfbain
Amsterdam UMC
Outcome results
None listed