Preoperative Breast Irradiation

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Radiation: pre-operative irradiation

• Registration Number: NCT02941835
• Lead Sponsor: The Netherlands Cancer Institute

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Study Start: 2018-03-12
• Primary Completion: 2018-08-09
• Study Completion: 2018-08-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiation	pre-operative irradiation	intervention: pre-operative breast irradiation of 21 fx of 2.2Gy and boost 2.66Gy

Primary Outcome Measures

Name	Time	Method
Postoperative surgical complications	within six weeks after surgery	postoperative complication will be scored by a specific list

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands