Clinical trial NCT05498311: Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Intraoperative radiotherapy
hypofractionated radiotherapy
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 89
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intraoperative Radiotherapy (IORT)
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Changes in Cosmetic results - BCCT
timeFrame: Baseline and every 12 months until 60 months
measure: Changes in Cosmetic results - Self Evaluation using YBT
timeFrame: Baseline and every 12 months until 60 months
Secondary outcomes:
measure: Changes in Quality of life (QOL) - General
timeFrame: Baseline and every 12 months until 60 months
measure: Toxicity (acute and late)
timeFrame: Baseline and every 12 months until 60 months
measure: Local control
timeFrame: Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years
measure: Changes in Quality of life (QOL) - Breast
timeFrame: Baseline and every 12 months until 60 months
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Evelyn Martínez
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia
name: Evelyn Martínez, MD
role: PRINCIPAL_INVESTIGATOR
References: