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Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer (PAPBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024582
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : September 27, 2017
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: accelerated partial breast irradiation
pre-operative radiation of the in situ tumor in the breast
Procedure: biopsy
before treatment a biopsy will be taken to confirm breast cancer type

Procedure: 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

Radiation: accelerated partial breast irradiation
Radiation: image-guided radiation therapy

Primary Outcome Measures :
  1. local recurrence [ Time Frame: 5 years ]
    Local recurrences should not exceed 4% at 5 years of follow-up

Secondary Outcome Measures :
  1. breast fibrosis [ Time Frame: 5 years ]
    decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%

  2. 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.

  3. Pathological response [ Time Frame: 6 weeks after finishing iradiation treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer
  • Must have undergone a sentinel node procedure prior to irradiation


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

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 identifier (NCT number): NCT01024582

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Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 BE
Sponsors and Collaborators
The Netherlands Cancer Institute
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Principal Investigator: Paula Elkhuizen, MD The Netherlands Cancer Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: The Netherlands Cancer Institute Identifier: NCT01024582    
Other Study ID Numbers: M08PBI
NL24996.031.08 ( Registry Identifier: CCMO )
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Netherlands Cancer Institute:
breast cancer
invasive breast cancer
adenocarcinoma of the breast
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases