Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer

Study Overview
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Brief Summary
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Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Detailed Description
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Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.

Official Title
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Phase II Study to Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for the Treatment of Early and Locally Advanced Breast Cancer

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Radiation: adjuvant ultra-hypofractionated radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient; Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile; Age greater than or equal to 65 years; Breast-conserving surgery or mastectomy with or without axillary approach With or without neoadjuvant or adjuvant systemic treatment Exclusion Criteria: Patients with previous thoracic irradiation; Patients with indication for bilateral thoracic irradiation; Patients with breast reconstruction with prosthesis or autologous tissue; Patients with compromised surgical margins after resection; pT1-pT2 pN0 patients undergoing radical mastectomy.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective phase 2 non-randomized single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Ultra-hypofractionated<br>5 fractions of 5.7 Gy every other day in the breast or chest wall region, with or without the inclusion of regional lymph node drainage chains | Radiation: adjuvant ultra-hypofractionated radiotherapy<br>* adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0 | Events of radiotherapy up to 3 months | 
| Late toxicity | Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification. | Events after 3 months of radiotherapy completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional free survival | from the date of initiation of treatment until the date of recurrence or progression of locoregional disease evidence | 3 years | 
| Distant free survival | from the date of initiation of treatment until the date of progression of distant disease evidence | 3 years | 
| Overall survival | defined from the date of initiation of treatment until the patient's death | 3 years | 
| Cosmesis change | was assessed using the Harvard/NSABP/RTOG scale. The Harvard/NSABP/RTOG scale score is a 4-point breast cosmetic scale, which was assessed by clinicians at baseline (after surgery) and two additional times during follow-up | week 10 and week 26 after the end of the treatment | 
| QOL (Quality of Life) changes | was assessed using the scales proposed by the EORTC (European Organization for Research and Treatment of Cancer). The EORTC QOL-C30 and EORTC QLQ-BR-23 scales. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Adjuvant radiotherapy, Ultra-hypofractionated