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

Netherlands Cancer Institute (NKI) logo

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%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

radiotherapy in arm 1
Experimental group
Description:
pre-operative accelerated partial breast irradiation
Treatment:
Radiation: partial breast irradiation
radiotherapy in arm 2
Active Comparator group
Description:
post-operative accelerated partial breast irradiation
Treatment:
Radiation: partial breast irradiation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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