Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer (PAPBI)
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.
Procedure: fine-needle aspiration
Radiation: accelerated partial breast irradiation
Radiation: image-guided radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity|
- local recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]Local recurrences should not exceed 4% at 5 years of follow-up
- breast fibrosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%
- cosmetic outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost.
- Pathological response [ Time Frame: 6 weeks after finishing iradiation treatment ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2026|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: accelerated partial breast irradiation
pre-operative radiation of the in situ tumor in the breast
before treatment a biopsy will be taken to confirm breast cancer typeProcedure: fine-needle aspiration
at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysisRadiation: accelerated partial breast irradiation Radiation: image-guided radiation therapy
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024582
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital||Recruiting|
|Amsterdam, Netherlands, 1066 BE|
|Contact: Contact Person 31-20-512-1714 firstname.lastname@example.org|
|Principal Investigator:||Paula Elkhuizen, MD||The Netherlands Cancer Institute|