Study Stopped
slow inclusion rate
Preoperative Breast Irradiation
PROBI
2 other identifiers
interventional
4
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Mar 2018
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedStudy Start
First participant enrolled
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2018
CompletedOctober 22, 2019
October 1, 2019
5 months
October 20, 2016
October 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative surgical complications
postoperative complication will be scored by a specific list
within six weeks after surgery
Secondary Outcomes (3)
Radiological response
6 weeks post-radiation
Pathological response
at surgery
cosmetic outcome
1,3 and 5 years post-treatment
Other Outcomes (1)
gene expression profiles
6 weeks
Study Arms (1)
radiation
OTHERintervention: pre-operative breast irradiation of 21 fx of 2.2Gy and boost 2.66Gy
Interventions
pre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Netherlands Cancer Institute
Amsterdam, 1066 CX, Netherlands
Related Publications (5)
Bartelink H, Maingon P, Poortmans P, Weltens C, Fourquet A, Jager J, Schinagl D, Oei B, Rodenhuis C, Horiot JC, Struikmans H, Van Limbergen E, Kirova Y, Elkhuizen P, Bongartz R, Miralbell R, Morgan D, Dubois JB, Remouchamps V, Mirimanoff RO, Collette S, Collette L; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):47-56. doi: 10.1016/S1470-2045(14)71156-8. Epub 2014 Dec 9.
PMID: 25500422BACKGROUNDDonker M, Straver ME, Wesseling J, Loo CE, Schot M, Drukker CA, van Tinteren H, Sonke GS, Rutgers EJ, Vrancken Peeters MJ. Marking axillary lymph nodes with radioactive iodine seeds for axillary staging after neoadjuvant systemic treatment in breast cancer patients: the MARI procedure. Ann Surg. 2015 Feb;261(2):378-82. doi: 10.1097/SLA.0000000000000558.
PMID: 24743607BACKGROUNDEgro FM, Pinell-White X, Hart AM, Losken A. The use of reduction mammaplasty with breast conservation therapy: an analysis of timing and outcomes. Plast Reconstr Surg. 2015 Jun;135(6):963e-971e. doi: 10.1097/PRS.0000000000001274.
PMID: 26017612BACKGROUNDJones HA, Antonini N, Hart AA, Peterse JL, Horiot JC, Collin F, Poortmans PM, Oei SB, Collette L, Struikmans H, Van den Bogaert WF, Fourquet A, Jager JJ, Schinagl DA, Warlam-Rodenhuis CC, Bartelink H. Impact of pathological characteristics on local relapse after breast-conserving therapy: a subgroup analysis of the EORTC boost versus no boost trial. J Clin Oncol. 2009 Oct 20;27(30):4939-47. doi: 10.1200/JCO.2008.21.5764. Epub 2009 Aug 31.
PMID: 19720914BACKGROUNDvan de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967.
PMID: 12490681BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Astrid Scholten, MD, PhD
Antoni van Leeuwenhoek
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 21, 2016
Study Start
March 12, 2018
Primary Completion
August 9, 2018
Study Completion
August 9, 2018
Last Updated
October 22, 2019
Record last verified: 2019-10