Clinical trial · Interventional
Accelerated Intensity Modulated Radiation Therapy (AIMRT) to the Breast After Segmental Mastectomy
Accelerated Intensity Modulated Radiation Therapy (AIMRT) to the Breast After Segmental Mastectomy: a Pilot Study
- 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)
The primary purpose of this study is to determine the feasibility and tolerability of a regimen of accelerated (hypofractionated) Intensity Modulated Radiation Therapy (AIMRT) to the whole breast as part of breast preservation. In addition, the investigators want to prospectively collect blood specimens to: assess TGF-β polymorphisms to identify potential carriers at higher risk for post-treatment fibrosis; generate a blood specimen repository for future studies of other relevant polymorphisms. The study investigators also want to prospectively follow each treated woman yearly to assess long-term radiation sequelae of the current regimen by using the LENT/SOMA scores.
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 |
|---|---|---|---|
| Accelerated intensity modulated radiation therapy (AIMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Accelerated intensity modulated radiation therapy (AIMRT)
- description
- All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.
- interventionNames
- Radiation: Accelerated intensity modulated radiation therapy (AIMRT)
Primary outcomes (5)
- measure
- Number of Participants With Local Recurrence in Breast
- timeFrame
- 5 years
- description
- Defined by the discovery of invasive disease or DCIS in the same region of the breast after segmental mastectomy and radiation, by clinical or radiographic means.
- measure
- Number of Participants With Regional Recurrence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Pre- or post-menopausal women with Stage I and II breast cancer * Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm * Status post segmental mastectomy. and after sentinel node biopsy and/or axillary node dissection * At least 2 weeks from last chemotherapy * Tumors \< 5 mm do not require nodal assessment Exclusion Criteria: * Previous radiation therapy to the ipsilateral breast. * More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation. * Active connective tissue disorders, such as lupus or scleroderma. * Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free \> 5 years. * Pregnant or lactating women.
References
Publications (0)
Data not yet available