Preoperative Breast Irradiation

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02941835

Acronym

PROBI

Enrollment

Registered

2016-10-21

Start date

2018-03-12

Completion date

2018-08-09

Last updated

2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

pre-operative radiotherapy

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

Interventions

RADIATIONpre-operative irradiation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Other

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026