RecruitingNot ApplicableNCT04669873

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

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


Sponsor

Instituto Brasileiro de Controle do Cancer

Enrollment

36 participants

Start Date

Mar 4, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation approaches for women with early-stage breast cancer who have had breast-conserving surgery (lumpectomy). One approach treats only the area where the tumor was removed (partial breast irradiation), while the other treats the whole breast. Researchers want to know if the more targeted approach is just as effective with fewer side effects. **You may be eligible if you:** - Are a woman aged 50 years or older - Have had breast-conserving surgery for early-stage invasive breast cancer - Have a tumor smaller than 3 cm with clear surgical margins - Have certain lower-risk cancer features (grade I or II, no lymph node involvement, no lymphovascular invasion) - Are in good health (ECOG 0–1) **You may NOT be eligible if you:** - Have had breast or chest radiation before - Have cancer that has spread elsewhere in the body - Have certain higher-risk tumor features (e.g., the classic invasive lobular type) - Have had a previous cancer (other than certain non-melanoma skin cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONActive Comparator: Standard

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

RADIATIONExperimental 1: Hypofractionated radiotherapy

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

RADIATIONExperimental 2: Accelerated Partial Breast Irradiation

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


Locations(1)

IBCC Oncologia

São Paulo, São Paulo, Brazil

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NCT04669873


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