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

September 27, 2022 updated by: The Netherlands Cancer Institute

Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.2 Gy

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Cloud, France, 92210
        • Institut Curie
      • Villejuif, France, 94805
        • Institut Gustave-Roussy
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Antoni van Leeuwenhoek
      • Utrecht, Netherlands, 3584CX
        • University Medical Center Utrecht (UMCU)
  • Portugal
      • Lisboa, Portugal, 1400-038
        • Champilamaud Cancer Center
  • Spain
      • Valencia, Spain, 46014
        • University General Hospital Valencia-Erasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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
  • pN+ (micro- or macrometastases)
  • 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
  • No social security affiliation/health insurance
  • Participation in another clinical trial that interferes with the locoregional treatment of this protocol
  • It is expected that dosimetric constraints cannot be met, ie, lung/heart constraints or if the ratio PTV/ipsilateral breast >30%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor response
Time Frame: 6 weeks
pathologic response will be measured in the removed tissue
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

Institut Curie

Investigators

  • Principal Investigator: Astrid Scholten, MD, PhD, The Netherlands Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2016

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15PAP
  • NL53862.031.15 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

data from this clinical trial will be shared with the previous PAPBI clinical trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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