Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)

Recruiting now · Phase 2

Conditions studied: Breast Cancer Female

In brief

Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions. The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

Key facts

Study ID: NCT05914831
Run by: Oncology Institute of Vojvodina
People needed: 100
Starts: 2023-06-01
Expected to finish: 2033-05-31
Last updated by the study team: 2023-07-03

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Breast-conserving surgery
Invasive ductal carcinoma
Age ≥ 50
Tumor size ≤ 3 cm
R0 resection
Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
Hormone receptor status - any
Histological grade G1 or G2

You may not qualify if…

Neoadjuvant systemic therapy
TNBC (triple-negative breast cancer)
Extensive intraductal component (EIC)
Lymphovascular invasion (LVI)
associated DCIS > 2.5 cm in size or high nuclear grade

Where it is running

Oncology Institute of Vojvodina — Novi Sad, Vojvodina, Serbia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.