NCT05464667

Preoperative Irradiation for Stage I Breast Cancer

Preoperative Irradiation for Stage I Breast Cancer: A Phase IB Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Parul Barry · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.

Detailed description

This trial is a dose escalation study where we will evaluate preoperative dose-escalated RT in four cohorts and determine the maximum tolerated dose (MTD)In the first cohort, patients will be assigned to receive the standard dose of 30 Gy in 5 fractions to the planning target volume (PTV) and 30 GY in 5 fractions to the gross target volume (GTV). In the subsequent cohorts patients will receive 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 35 Gy, 40 Gy, and 50 Gy respectively. An interim analysis will be performed after 40 Gy to assess toxicity.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy (RT)	Dose Escalation: 4 Cohorts - 30 GY in 5 fractions (baseline treatment with 0 boost dose to GTV), 35, 40, 50 Gy in 5 fractions (Par 1) Dose Expansion: Maximum Tolerated Dose determined during dose escalation (Part 2)

Timeline

• Start date: 2023-07-07
• Primary completion: 2026-04-30
• Completion: 2028-03-31
• First posted: 2022-07-19
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study