Preoperative Breast Irradiation

Breast Cancer Clinical Trial

— PROBI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02941835
• Other study ID #: N16PRB
• Secondary ID: NL59561.031.16
• Status: Terminated
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: August 9, 2018

Study information

• Verified date: October 2019
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 9, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• pre-operative irradiation
pre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

References & 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. Erratum in: Lancet Oncol. 2015 Jan;16(1):e6. — View 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. — View 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. — View 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, Wárlám-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	gene expression profiles	at start a biopsy will be taken and compared to the surgical specimen at 6 weeks post treatment	6 weeks
Primary	Postoperative surgical complications	postoperative complication will be scored by a specific list	within six weeks after surgery
Secondary	Radiological response	assessed by MRI	6 weeks post-radiation
Secondary	Pathological response	surgery specimen	at surgery
Secondary	cosmetic outcome	cosmesis will be scored by physician by questionnaire and cosmesis will be cored by patient by questionnaire	1,3 and 5 years post-treatment