Preoperative Breast Irradiation (PROBI)

October 18, 2019 updated by: The Netherlands Cancer Institute

Preoperative Breast Irradiation, the PROBI Trial. A Phase I/II Feasibility Trial

The PROBI is a phase I/II trial assessing the feasibility of preoperative whole breast irradiation in female patients with low to intermediate risk breast cancer, who undergo breast conserving therapy, including a boost dose of irradiation.

An additional goal of this study is to assess tumor response to radiotherapy, by imaging modalities (PET-CT and MRI) and pathology

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute

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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically proven invasive breast carcinoma
  • cT1-2N0 breast cancer
  • cM0
  • female patients ≤ 50 years
  • planned breast conserving surgery
  • ability to undergo irradiation and surgery
  • signed written informed consent

Exclusion Criteria:

  • prior surgery or radiotherapy for the protocol tumor (neoadjuvant chemotherapy or endocrine therapy is allowed)
  • planned oncoplastic reduction mammoplasty
  • cTis
  • extensive calcifications on mammagram (Birads 3,4 or 5)
  • cT3-4 and/or cN1-3 invasive carcinoma
  • distant metastasis

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: radiation
intervention: pre-operative breast irradiation of 21 fx of 2.2Gy and boost 2.66Gy
Radiation: pre-operative irradiation
pre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy
Other Names:
  • radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative surgical complications
Time Frame: within six weeks after surgery
postoperative complication will be scored by a specific list
within six weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological response
Time Frame: 6 weeks post-radiation
assessed by MRI
6 weeks post-radiation
Pathological response
Time Frame: at surgery
surgery specimen
at surgery
cosmetic outcome
Time Frame: 1,3 and 5 years post-treatment
cosmesis will be scored by physician by questionnaire and cosmesis will be cored by patient by questionnaire
1,3 and 5 years post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
gene expression profiles
Time Frame: 6 weeks
at start a biopsy will be taken and compared to the surgical specimen at 6 weeks post treatment
6 weeks

Collaborators and Investigators

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

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Astrid Scholten, MD, PhD, Antoni van Leeuwenhoek

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)

March 12, 2018

Primary Completion (ACTUAL)

August 9, 2018

Study Completion (ACTUAL)

August 9, 2018

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (ESTIMATE)

October 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N16PRB
  • NL59561.031.16 (REGISTRY: CCMO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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