Pre- Versus Postoperative Accelerated Partial Breast Irradiation

Last updated: September 27, 2022
Sponsor: The Netherlands Cancer Institute
Overall Status: Terminated

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT02913729
M15PAP
NL53862.031.15
  • Ages > 51
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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 tumorare accepted as long as it is suitable for local excision to be determined by theparticipating centre)
  • World Health Organization performance status ≤ 2
  • Life expectancy ≥ 5 years
  • Written informed consent

Exclusion

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 orneoadjuvant 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 locoregionaltreatment of this protocol
  • It is expected that dosimetric constraints cannot be met, ie, lung/heart constraintsor if the ratio PTV/ipsilateral breast >30%

Study Design

Total Participants: 65
Study Start date:
November 10, 2016
Estimated Completion Date:
February 28, 2022

Study Description

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

Connect with a study center

  • Institut Curie

    Saint-Cloud, 92210
    France

    Site Not Available

  • Institut Gustave-Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Radboud University Medical Center

    Nijmegen, Gelderland 6500 HB
    Netherlands

    Site Not Available

  • Antoni van Leeuwenhoek

    Amsterdam, 1066CX
    Netherlands

    Site Not Available

  • University Medical Center Utrecht (UMCU)

    Utrecht, 3584CX
    Netherlands

    Site Not Available

  • Champilamaud Cancer Center

    Lisboa, 1400-038
    Portugal

    Site Not Available

  • University General Hospital Valencia-Erasa

    Valencia, 46014
    Spain

    Site Not Available

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