Pre- versus Postoperative Accelerated Partial Breast Irradiation in early stage breast cancer patients

Phase 3

Completed

Conditions: breast cancer
10006291

Registration Number: NL-OMON55435

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

* Female patients * 51 years
* cT1-2 (* 3 cm)
* cN0
* Grade I or grade II (biopsy)
* Histologically proven invasive ductal adenocarcinoma
* Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to
the tumor are accepted as long as it is suitable for local excision to be
determined by the participating centre)
* WHO performance * 2
* Life expectancy * 5 years
* Written informed consent

Exclusion Criteria

* Distant metastases
* Lobular invasive carcinomas
* Pure DCIS without invasive tumor
* Grade III in biopsy
* Triple negative tumors
* HER2neu positive tumors
* Lymphvascular invasion in biopsy
* cN1-3
* pN+ (Micro- or macrometastases
* Multicentric / multifocal disease on mammogram or MRI
* Diffuse calcifications on mammogram (Birads 3, 4 or 5)
* Prior treatment for the protocol tumor (no surgery, no neoadjuvant
chemotherapy or neoadjuvant hormonal therapy, no previous radiotherapy)
* Previous contralateral breast cancer:
* Other neoplasms in the last 5 years with the exception of:
- Basal cell carcinoma of the skin
- Adequately treated carcinoma in situ of the cervix
* Planned oncoplastic resection with tissue displacement
* No social security affiliation/health insurance
* Participation in another clinical trial that interferes with the locoregional
treatment of this protocol
* It is expected that dosimetric constraints cannot be met, ie, lung/heart
constraints (see 6.1.5), or if the ratio PTV/ ipsilateral breast >30%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cosmetic outcome at 3 years</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Fibrosis/induration<br /><br>* Breast pain<br /><br>* Local relapse free survival<br /><br>* Quality of life<br /><br>* Disease free survival<br /><br>* Distant metastases free survival<br /><br>* Overall survival</p><br>