Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Yonsei University
- Enrollment
- 747
- Locations
- 1
- Primary Endpoint
- Disease-free survival
Study Overview
Brief Summary
The aim of this study is to find out whether the inclusion of internal mammary node irradiation in regional nodal irradiation improves outcomes in women with node-positive breast cancer.
Detailed Description
This is a multicenter, prospective, randomized phase 3 trial. Patients with node-positive breast cancer without distant metastases were included. All patients underwent breast conservation surgery or mastectomy with axillary lymph node dissection before irradiation. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with ≥8 nodes removed.
Exclusion Criteria
- •Neoadjuvant chemotherapy
- •Bilateral breast cancer
- •Distant metastasis
- •History of other malignancy
- •Involvement of supraclavicular nodes or internal mammary nodes at diagnosis
Arms & Interventions
Internal mammary node irradiation
Intervention: Internal mammary node irradiation (Radiation)
No internal mammary node irradiation
Intervention: No internal mammary node irradiation (Radiation)
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: 7 years
Secondary Outcomes
- breast cancer-specific survival(7 years)
- Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3(7 years)
- Rates of overall survival(7 years)