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Pre- Versus Postoperative Accelerated Partial Breast Irradiation (PAPBI-2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913729
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

Condition or disease Intervention/treatment Phase
Breast Cancer Cancer of the Breast Neoplasms, Breast Radiation: partial breast irradiation Not Applicable

Detailed Description:
Patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.7 Gy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients
Actual Study Start Date : November 10, 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: radiotherapy in arm 1
pre-operative accelerated partial breast irradiation
Radiation: partial breast irradiation
irradiation
Other Names:
  • partial breast radiotherapy
  • accelerated breast irradiation

Active Comparator: radiotherapy in arm 2
post-operative accelerated partial breast irradiation
Radiation: partial breast irradiation
irradiation
Other Names:
  • partial breast radiotherapy
  • accelerated breast irradiation




Primary Outcome Measures :
  1. Cosmetic outcome [ Time Frame: 3 years ]
    cosmetic effect will be measured by comparing the treated breast with the contralateral breast. Cosmetic effect will be scored in three different ways: by digital photographs, patient's questionnaires and specialist's questionnaires. These data will result in an overall cosmetic outcome, scored as excellent, good, fair or poor.


Secondary Outcome Measures :
  1. tumor response [ Time Frame: 6 weeks ]
    pathologic response will be measured in the removed tissue

  2. postoperative complications [ Time Frame: 6 weeks ]
    The expected acute surgical complication rate is approximately 16%. A stopping rule is set at 15% for complications that require hospitalization (including intravenous antibiotics) and re-surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients ≥ 51 years
  • clinical stage tumor-1-2 (≤ 3 cm)
  • cN0
  • Grade I or grade II (biopsy)
  • Histologically proven invasive ductal adenocarcinoma
  • Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision to be determined by the participating centre)
  • World Health Organization performance status ≤ 2
  • Life expectancy ≥ 5 years
  • Written informed consent

Exclusion Criteria:

  • Distant metastases
  • Lobular invasive carcinomas
  • Pure Ductal Carcinoma in situ (DCIS) without invasive tumor
  • Grade III in biopsy
  • Triple negative tumors
  • HER2neu positive tumors
  • Lymphvascular invasion in biopsy
  • TNM pathologic stage N1-3
  • pN1-3
  • Multicentric / multifocal disease on mammogram or MRI
  • Diffuse calcifications on mammogram (Birads 3, 4 or 5)
  • Prior treatment for the protocol tumor (no surgery, no neoadjuvant chemotherapy or neoadjuvant hormonal therapy, no previous radiotherapy)
  • Previous contralateral breast cancer
  • Other neoplasms in the last 5 years with the exception of:
  • Basal cell carcinoma of the skin
  • Adequately treated carcinoma in situ of the cervix
  • Planned oncoplastic resection with tissue displacement

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 ClinicalTrials.gov identifier (NCT number): NCT02913729


Contacts
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Contact: Astrid Scholten, MD, PhD +31 20 512 9111 a.scholten@nki.nl
Contact: Nicola Russell, MD, PhD +31 20 512 9111 n.russell@nki.nl

Locations
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Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Paulien G Westhoff, MD, PhD    +31616423821    Paulien.Westhoff@radboudumc.nl   
Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Astrid Scholten, MD, PhD    +31 20 512 9111    a.scholten@nki.nl   
Contact: Nicola Russell, MD, PhD    +31 20 512 9111    n.russell@nki.nl   
Portugal
Champilamaud Cancer Center Recruiting
Lisboa, Portugal, 1400-038
Contact: Marco Passanzini, MD, PhD    +351 210 480 048    marco.possanzini@fundacaochampalimaud.pt   
Spain
University General Hospital Valencia-Erasa Recruiting
Valencia, Spain, 46014
Contact: Amparo Gonzalez Sanchis, MD, PhD    +34 96 346 88 53    agonzales@erasa.com   
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Astrid Scholten, MD, PhD The Netherlands Cancer Institute
Publications:

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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02913729    
Other Study ID Numbers: M15PAP
NL53862.031.15 ( Other Identifier: CCMO )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data from this clinical trial will be shared with the previous PAPBI clinical trial
Keywords provided by The Netherlands Cancer Institute:
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases