Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

Breast Cancer Clinical Trial

— IORT_BREAST  

Official title:

Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498311
• Other study ID #: IORT BREAST CANCER
• Status: Recruiting
• Phase: Phase 2
• Start date: October 20, 2016
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Institut Català d'Oncologia
• Contact: Evelyn Martínez, MD
• Phone: +34 93 260 77 20
• Email: emperez[@]iconcologia.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

Description:

To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy.
• Not pregnant at diagnosis.
• Signed informed consent form.
• Age =45 years old.
• Patients candidates to Intrabeam.
• Patients with =60 years with the presence of one or more of the following adverse

criteria after surgery:

• Tumor size > 2.5 cm.
• Extensive intraductal carcinoma (=25%)
• Lymphovascular invasion.
• Involved focal margins (<2mm) without ampliation surgery.

Exclusion Criteria:

• Presence of distant metastasis.
• Primary chemotherapy.
• Lymph node involvement.
• Negative hormonal receptors.
• Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
• Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
• Uncontrolled infection.
• Concurrent treatment with other experimental treatments
• Lack of signed informed consent form.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Intraoperative Radiotherapy (IORT)
The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery

Procedure:
• Breast conservative surgery
Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery

Radiation:
• External Beam Hypofractionated Radiotherapy (EBRT)
A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.

Locations

Country	Name	City	State
Spain	Evelyn Martínez	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Català d'Oncologia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cosmetic results - BCCT	It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor)	Baseline and every 12 months until 60 months
Primary	Changes in Cosmetic results - Self Evaluation using YBT	Questionnaire for cosmetic self-evaluation from the Young Boost Trial (YBT) that consists s of 8 questions about various aspects (size, shape, skin colour, massiveness of the breast, nipple position, general appearance, visibility of the surgical scar, and overall satisfaction) to evaluate the degree of satisfaction of the patients themselves about the cosmetic results.	Baseline and every 12 months until 60 months
Secondary	Changes in Quality of life (QOL) - General	It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30	Baseline and every 12 months until 60 months
Secondary	Toxicity (acute and late)	Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0	Baseline and every 12 months until 60 months
Secondary	Local control	Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast	Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years
Secondary	Changes in Quality of life (QOL) - Breast	It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23	Baseline and every 12 months until 60 months