Preoperative Breast Irradiation (PROBI)

Netherlands Cancer Institute (NKI)

Status: Terminated

Conditions: Breast Cancer

Treatments: Radiation: pre-operative irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02941835

N16PRB

NL59561.031.16 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

radiation

Other group

Description:

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

Treatment:

Radiation: pre-operative irradiation