Pre- Versus Postoperative Accelerated Partial Breast Irradiation

Not Applicable

Terminated

• Conditions: Breast Cancer; Cancer of the Breast; Neoplasms, Breast
• Interventions: Radiation: partial breast irradiation

• Registration Number: NCT02913729
• Lead Sponsor: The Netherlands Cancer Institute

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

Study Timeline

• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-26
• Study Start: 2016-11-10
• Status Verified: 2021-12
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 65

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiotherapy in arm 1	partial breast irradiation	pre-operative accelerated partial breast irradiation
radiotherapy in arm 2	partial breast irradiation	post-operative accelerated partial breast irradiation

Primary Outcome Measures

Name	Time	Method
Cosmetic outcome	3 years	cosmetic effect will be measured by comparing the treated breast with the contralateral breast. Cosmetic effect will be scored in three different ways: by digital photographs, patient's questionnaires and specialist's questionnaires. These data will result in an overall cosmetic outcome, scored as excellent, good, fair or poor.

Secondary Outcome Measures

Name	Time	Method
postoperative complications	6 weeks	The expected acute surgical complication rate is approximately 16%. A stopping rule is set at 15% for complications that require hospitalization (including intravenous antibiotics) and re-surgery
tumor response	6 weeks	pathologic response will be measured in the removed tissue

Trial Locations

Locations (6)

Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, Netherlands

University Medical Center Utrecht (UMCU); 🇳🇱 Utrecht, Netherlands

Champilamaud Cancer Center; 🇵🇹 Lisboa, Portugal

University General Hospital Valencia-Erasa; 🇪🇸 Valencia, Spain

Institut Curie; 🇫🇷 Saint-Cloud, France

Institut Gustave-Roussy; 🇫🇷 Villejuif, France