Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer (PAPBI)
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|ClinicalTrials.gov Identifier: NCT01024582|
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : September 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: biopsy Procedure: fine-needle aspiration Radiation: accelerated partial breast irradiation Radiation: image-guided radiation therapy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
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
- local recurrence [ Time Frame: 5 years ]Local recurrences should not exceed 4% at 5 years of follow-up
- breast fibrosis [ Time Frame: 5 years ]decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%
- cosmetic outcome [ Time Frame: 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 [ Time Frame: 6 weeks after finishing iradiation treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024582
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 BE|
|Principal Investigator:||Paula Elkhuizen, MD||The Netherlands Cancer Institute|