Clinical trial NCT02941835: Preoperative Breast Irradiation
Official title: Preoperative Breast Irradiation, the PROBI Trial. A Phase I/II Feasibility Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: pre-operative radiotherapy
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative surgical complications
timeFrame: within six weeks after surgery
Secondary outcomes:
measure: Radiological response
timeFrame: 6 weeks post-radiation
measure: Pathological response
timeFrame: at surgery
measure: cosmetic outcome
timeFrame: 1,3 and 5 years post-treatment
Other outcomes:
measure: gene expression profiles
timeFrame: 6 weeks
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
Study officials:
affiliation: Antoni van Leeuwenhoek
name: Astrid Scholten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Erratum In: Lancet Oncol. 2015 Jan;16(1):e6.
citation: Donker 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.
citation: Egro 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.
citation: Jones 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.
citation: van 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.