N/A
N=30
Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00508352 ↗Enrolled (actual)
30
Serious AEs
16.7%
Results posted
Jun 2025
Primary outcome: Primary: Acute Radiation Effects (Less Than 90 Days Post Treatment) — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Helical tomotherapy IMRT (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Radiation Effects (Less Than 90 Days Post Treatment) |
— | — |
| PRIMARY Moderate-late Pulmonary and Cardiac Radiation Effects |
— | — |
| SECONDARY Rate of Local Recurrence |
— | — |
| SECONDARY Rate of Regional Recurrence |
— | — |
Summary
Research has shown that treatment with conventional radiation techniques and chemotherapy following mastectomy or breast conserving surgery has resulted in better rates of locoregional control and overall survival in stage IIB-III breast cancer. The current feasibility trial using the most recent advance in radiation therapy, namely helical tomotherapy intensity modulated radiation therapy (HT-IMRT), hopes to improve on the results of conventional radiation by decreasing the amount of radiation-induced toxicity in patients with stage IIb-III breast cancer.
Eligibility Criteria
Inclusion Criteria
- Surgery with either mastectomy or breast conserving surgery
- Presence and association of any of the following high risk pathological features present at time of surgery: stage pT3-4 and pN0 and central/medial location of tumour or any pT and pN2 (stage IIB-stage III)
- All patients will have been treated previously with chemotherapy prior to radiation therapy
- ECOG performance status of 2 or less
Exclusion Criteria
- Prior chest wall/breast or nodal radiation for other malignancies (i.e. Hodgkin disease)
- HER2+ positive patients
- Patients with diagnosis of metastatic disease
- Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of breast cancer
Data sourced from ClinicalTrials.gov (NCT00508352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.