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Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery

ConditionMalignant Neoplasm of Breast
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-90
SponsorInstituto Brasileiro de Controle do Cancer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Previous malignancy (except non-melanomatous skin cancer)

Mastectomy

Classical-Type Invasive Lobular Carcinoma

Neoadjuvant chemotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Comparator: Standard

    Radiation

    Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks

  • Experimental 1: Hypofractionated radiotherapy

    Radiation

    Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week

  • Experimental 2: Accelerated Partial Breast Irradiation

    Radiation

    Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Active Comparator: StandardActive comparator 1 intervention
Group B: Experimental 1: Hypofractionated radiotherapyExperimental treatment 1 intervention
Group C: Experimental 2: Accelerated Partial Breast IrradiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of local recurrence

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

Time frame
5 years

Secondary outcomes

1

Time to occurrence of distant metastases

Distant tumor time is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up.

Time frame
5 years
2

Disease-free survival

Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.

Time frame
5 years
3

Overall survival

Overall survival time, defined as number of days from randomization until death or end of follow-up.

Time frame
5 years
4

Medico-economic study

To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation

Time frame
Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Brasileiro de Controle do Cancer

Lead sponsor

Source ClinicalTrials.gov
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