Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy (IORT_BREAST)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Intraoperative Radiotherapy (IORT)
Breast conservative surgery
External Beam Hypofractionated Radiotherapy (EBRT)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Intraoperative radiotherapy, hypofractionated radiotherapy
Eligibility Criteria
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.
Sites / Locations
- Evelyn MartínezRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraoperative Radiotherapy (IORT)
Arm Description
Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy.
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
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
Toxicity (acute and late)
Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Local control
Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast
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
Full Information
NCT ID
NCT05498311
First Posted
April 8, 2021
Last Updated
August 11, 2022
Sponsor
Institut Català d'Oncologia
1. Study Identification
Unique Protocol Identification Number
NCT05498311
Brief Title
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Català d'Oncologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Intraoperative radiotherapy, hypofractionated radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Intraoperative Radiotherapy (IORT)
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative Radiotherapy (IORT)
Arm Type
Experimental
Arm Description
Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Intraoperative Radiotherapy (IORT)
Intervention Description
The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
Intervention Type
Procedure
Intervention Name(s)
Breast conservative surgery
Intervention Description
Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery
Intervention Type
Radiation
Intervention Name(s)
External Beam Hypofractionated Radiotherapy (EBRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Cosmetic results - BCCT
Description
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)
Time Frame
Baseline and every 12 months until 60 months
Title
Changes in Cosmetic results - Self Evaluation using YBT
Description
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.
Time Frame
Baseline and every 12 months until 60 months
Secondary Outcome Measure Information:
Title
Changes in Quality of life (QOL) - General
Description
It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30
Time Frame
Baseline and every 12 months until 60 months
Title
Toxicity (acute and late)
Description
Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame
Baseline and every 12 months until 60 months
Title
Local control
Description
Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast
Time Frame
Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years
Title
Changes in Quality of life (QOL) - Breast
Description
It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23
Time Frame
Baseline and every 12 months until 60 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evelyn Martínez, MD
Phone
+34 93 260 77 20
Email
emperez@iconcologia.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyn Martínez, MD
Organizational Affiliation
Institut Català d'Oncologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evelyn Martínez
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Martínez, MD
Phone
+34 93 260 77 20
Email
emperez@iconcologia.net
12. IPD Sharing Statement
Learn more about this trial
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy
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