Pre- Versus Postoperative Accelerated Partial Breast Irradiation (PAPBI-2)

Netherlands Cancer Institute (NKI)

Status

Terminated

Conditions

Neoplasms, Breast

Breast Cancer

Cancer of the Breast

Treatments

Radiation: partial breast irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT02913729

NL53862.031.15 (Other Identifier)

M15PAP

Details and patient eligibility

About

Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

Full description

Patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.2 Gy

Enrollment

65 patients

Sex

Female

Ages

51+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients ≥ 51 years
clinical stage tumor-1-2 (≤ 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)
World Health Organization performance status ≤ 2
Life expectancy ≥ 5 years
Written informed consent

Exclusion criteria

Distant metastases
Lobular invasive carcinomas
Pure Ductal Carcinoma in situ (DCIS) without invasive tumor
Grade III in biopsy
Triple negative tumors
HER2neu positive tumors
Lymphvascular invasion in biopsy
TNM pathologic stage N1-3
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 or if the ratio PTV/ipsilateral breast >30%