Clinical trial NCT04669873: Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery
Official title: Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Neoplasm of Breast
Keywords: Breast Cancer
Radiotherapy
Hypofractionated
Breast-conserving surgery
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 36
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.

There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.

Detailed description: The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.

Eligibility criteria: Inclusion Criteria:

* Information to the patient and signed informed consent;
* Women aged ≥50 years
* Breast conserving surgery
* Pathologic tumor size \< 3 cm (maximum microscopic diameter of the invasive component)
* Invasive adenocarcinoma (except classic invasive lobular carcinoma)
* Unifocal disease
* Histopathologic grades I or II
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Lymphovascular invasion absent
* Negative axillary lymph nodes
* Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
* No prior breast or mediastinal radiotherapy
* No hematogenous metastases

Exclusion Criteria:

* Previous malignancy (except non-melanomatous skin cancer)
* Mastectomy
* Classical-Type Invasive Lobular Carcinoma
* Neoadjuvant chemotherapy
* Human Epidermal growth factor Receptor-type 2 positive (HER2+)
* Triple-negative breast cancers
* Intravascular lymphoma present
* Contraindications to radiotherapy.
* No geographical, social or psychologic reasons that would prevent study follow

Primary outcomes:
measure: Rate of local recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Time to occurrence of distant metastases
timeFrame: 5 years
measure: Disease-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Medico-economic study
timeFrame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
measure: Health-related Quality of Life
timeFrame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
measure: Evaluation of quality of life change by European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
timeFrame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
measure: Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)
timeFrame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
measure: Measurement Satisfaction of Body Image of the participants
timeFrame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
measure: Changes in anxiety and depression
timeFrame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
measure: Early and late adverse effects in normal tissues
timeFrame: 5 years
measure: Late adverse effects
timeFrame: 5 years
measure: Acute toxicity rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: IBCC Oncologia
state: SP
Study officials:
References:
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