Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer
NCT ID: NCT01024582
Last Updated: 2017-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2009-10-31
2017-02-28
Brief Summary
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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
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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accelerated partial breast irradiation
pre-operative radiation of the in situ tumor in the breast
biopsy
before treatment a biopsy will be taken to confirm breast cancer type
fine-needle aspiration
at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis
accelerated partial breast irradiation
image-guided radiation therapy
Interventions
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biopsy
before treatment a biopsy will be taken to confirm breast cancer type
fine-needle aspiration
at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis
accelerated partial breast irradiation
image-guided radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
60 Years
120 Years
ALL
No
Sponsors
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The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Paula Elkhuizen, MD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Locations
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Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Countries
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References
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van der Leij F, Bosma SC, van de Vijver MJ, Wesseling J, Vreeswijk S, Rivera S, Bourgier C, Garbay JR, Foukakis T, Lekberg T, van den Bongard DH, van Vliet-Vroegindeweij C, Bartelink H, Rutgers EJ, Elkhuizen PH. First results of the preoperative accelerated partial breast irradiation (PAPBI) trial. Radiother Oncol. 2015 Mar;114(3):322-7. doi: 10.1016/j.radonc.2015.02.002. Epub 2015 Feb 17.
Other Identifiers
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NL24996.031.08
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20989
Identifier Type: -
Identifier Source: secondary_id
M08PBI
Identifier Type: -
Identifier Source: org_study_id