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

Prevent Senior Institute

Status and phase: Completed; Phase 2

Conditions: Breast Cancer Female

Treatments: Radiation: adjuvant ultra-hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05850637

INSTITUTO PREVENT SENIOR - IPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Single Arm Ultra-hypofractionated

Experimental group

Description:

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

Treatment:

Radiation: adjuvant ultra-hypofractionated radiotherapy