CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Partial Breast Irradiation (PBI)radiation
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically confirmed unicentric Stage I (T1N0M0) invasive ductal carcinoma
  • ✓Tumor margin ≥2 mm from inked edges, or no tumor in re-excision/final shaved specimen
  • ✓Low-grade DCIS (I and II) ≤2 cm with negative margins ≥2 mm or negative re-excision
  • ✓Women ≥70 years with ER+ T1 IDC, clinically negative axillary nodes, not undergoing surgical lymph node evaluation, eligible if taking hormonal therapy
Key exclusion· 13
  • ✕Multicentric IDC: discontiguous tumors ≥5 cm apart or in separate quadrants/subareolar region
  • ✕Multifocal IDC: discontiguous discrete foci within 5 cm span or same quadrant/subareolar region
  • ✕Tumor >2.0 cm, nodal involvement on H&E, or metastatic disease
  • ✕Lymphovascular invasion (tumor embolus in endothelial-lined space)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00325598
NCT00325598Phase 2Completed
CompareCT.gov

Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer: A Phase I/II Feasibility Study

Washington University School of Medicine·interventional·Posted May 15, 2006·Updated Jun 6, 2018

In Brief

A Phase 2 clinical trial evaluating Partial Breast Irradiation (PBI) for Breast Neoplasms. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2006
Enrollment StartFeb 14, 2006
Primary CompletionApr 16, 2013
Study CompletionApr 16, 2017
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.1 years ago

Interventions

Partial Breast Irradiation (PBI)radiation