N/A
Completed N=314
Accelerated Intensity Modulated Radiation Therapy (AIMRT) to the Breast After Segmental Mastectomy
Source: ClinicalTrials.gov NCT02606708 ↗Enrolled (actual)
314
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Number of Participants With Local Recurrence in Breast — 6 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local Recurrence in Breast |
6 | — |
| PRIMARY Number of Participants With Regional Recurrence |
4 | — |
| PRIMARY Number of Participants With Contralateral Breast Cancer |
2 | — |
| PRIMARY Number of Participants With Distant Metastases |
8 | — |
| PRIMARY Number of Participants With an Outcome of Death |
17 | — |
| SECONDARY Maximum Grade Late Radiation Toxicity |
62; 2; 0; 59; 13; 1 | — |
| SECONDARY Patient Self-assessment of the Cosmetic Results |
251; 56; 7 | — |
| SECONDARY Survival |
94.6 | — |
Eligibility Criteria
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 years.
- Pregnant or lactating women.
Data sourced from ClinicalTrials.gov (NCT02606708). 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. Informational only — not medical advice.