Breast Cancer
Conditions
Keywords
breast cancer, invasive breast cancer, adenocarcinoma of the breast
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.
Detailed description
OBJECTIVES: * is to investigate the impact of a short fractionated schedule given preoperatively on local control, cosmesis and breast fibrosis. * To further design optimal treatment strategies for individual breast cancer patients treated with breast-conserving therapy (BCT) on the basis of biological parameters, including the expression profile of the primary tumor, for both m-RNA as for micro-RNA, with first, a focus on radiotherapy responsiveness and second, on local recurrence rate, distant metastases and survival. * proteomics will be studied in fine-needle aspiration samples. A classifier can be build (genomic or proteomic or any kind of molecular signature) to identify responders and non-responders * quality of life OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation (PAPBI) 10 times over 12 days (10 x 4 Gy) and later in the study 5 times 6 Gy. Six weeks after completion of image-guided PAPBI, patients undergo surgery.
Interventions
before treatment a biopsy will be taken to confirm breast cancer type
at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer * Must have undergone a sentinel node procedure prior to irradiation PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local recurrence | 5 years | Local recurrences should not exceed 4% at 5 years of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| breast fibrosis | 5 years | decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15% |
| cosmetic outcome | 5 years | is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost. |
| Pathological response | 6 weeks after finishing iradiation treatment | — |
Countries
Netherlands