Clinical trial · Interventional
Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer
Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which radiation therapy schedule is more effective in treating breast cancer. PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (control)
- description
- Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
- interventionNames
- Radiation: intensity-modulated radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
- interventionNames
- Radiation: intensity-modulated radiation therapy
- type
- EXPERIMENTAL
- label
- Arm III
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * Resectable, unilateral disease * T1-3, N0-1, M0 disease * Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer * Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following: * Age 18-49 years * Tumor size \> 2.0 cm after primary surgery (maximum microscopic diameter of invasive component) * Tumor of any size treated by primary medical therapy * Grade III disease * Minimum microscopic margin of noncancerous tissue \< 5 mm (excluding deep margin if at deep fascia) * Lymphovascular invasion * Axillary node positive * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior mastectomy * No concurrent chemotherapy except primary or sequential chemotherapy
References
Publications (0)
Data not yet available