Clinical trial NCT05850637: Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer
Official title: Phase II Study to Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for the Treatment of Early and Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer Female
Keywords: Breast Cancer
Adjuvant radiotherapy
Ultra-hypofractionated
Lead sponsor: Prevent Senior Institute
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective phase 2 non-randomized single-arm study
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Female patient;
2. Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
3. Age greater than or equal to 65 years;
4. Breast-conserving surgery or mastectomy with or without axillary approach
5. With or without neoadjuvant or adjuvant systemic treatment

Exclusion Criteria:

1. Patients with previous thoracic irradiation;
2. Patients with indication for bilateral thoracic irradiation;
3. Patients with breast reconstruction with prosthesis or autologous tissue;
4. Patients with compromised surgical margins after resection;
5. pT1-pT2 pN0 patients undergoing radical mastectomy.

Primary outcomes:
measure: Acute toxicity
timeFrame: Events of radiotherapy up to 3 months
measure: Late toxicity
timeFrame: Events after 3 months of radiotherapy completion
Secondary outcomes:
measure: Locoregional free survival
timeFrame: 3 years
measure: Distant free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Cosmesis change
timeFrame: week 10 and week 26 after the end of the treatment
measure: QOL (Quality of Life) changes
timeFrame: 3 years
Other outcomes:
measure: Breast volume and toxicity relationship
timeFrame: 3 years
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Pesquisa Prevent Senior
Study officials:
affiliation: Instituto de Pesquisa Prevent Senior
name: Marcel MF Fang, MD
role: PRINCIPAL_INVESTIGATOR
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