Clinical trial NCT02913729: Pre- Versus Postoperative Accelerated Partial Breast Irradiation
Official title: Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Cancer of the Breast
Neoplasms, Breast
Keywords: breast cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Institut Curie
First posted: 2016-09-26
Enrollment: 65
Sex: FEMALE
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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%

Primary outcomes:
measure: Cosmetic outcome
timeFrame: 3 years
Secondary outcomes:
measure: tumor response
timeFrame: 6 weeks
measure: postoperative complications
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Saint-Cloud
country: France
facility: Institut Curie
city: Villejuif
country: France
facility: Institut Gustave-Roussy
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht (UMCU)
city: Lisboa
country: Portugal
facility: Champilamaud Cancer Center
city: Valencia
country: Spain
facility: University General Hospital Valencia-Erasa
Study officials:
affiliation: The Netherlands Cancer Institute
name: Astrid Scholten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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