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Clinical Trials/NCT04669873
NCT04669873RecruitingNot Applicable

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

Instituto Brasileiro de Controle do Cancer2 sites in 1 country36 target enrollmentStarted: March 4, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
36
Locations
2
Primary Endpoint
Rate of local recurrence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Rate of local recurrence

Time Frame: 5 years

To estimate and compare the rate of local recurrence between the experimental and control arms.

Secondary Outcomes

  • Acute toxicity rate(5 years)
  • Medico-economic study(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
  • Time to occurrence of distant metastases(5 years)
  • Overall survival(5 years)
  • Health-related Quality of Life(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
  • 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)(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
  • Late adverse effects(5 years)
  • Early and late adverse effects in normal tissues(5 years)
  • Disease-free survival(5 years)
  • Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
  • Measurement Satisfaction of Body Image of the participants(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
  • Changes in anxiety and depression(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eduardo Barbieri

Principal Investigator

Instituto Brasileiro de Controle do Cancer

Study Sites (2)

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