Clinical trial · Interventional
Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers
Hypo-Fractionated Conformal Radiation Therapy to the Tumor Bed After Segmental Mastectomy
NCT02883985CI-TRIAL-00036237completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with 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 |
|---|---|---|---|
| 6 Gy/ fraction | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Therapy: 6 Gy/ fraction
- description
- All patients will be treated with 6 Gy /fraction delivered in 5 fractions over a 2 week period for a total dose of 30 Gy.
- interventionNames
- Radiation: 6 Gy/ fraction
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- Up to 5 years
Secondary outcomes (2)
- measure
- TGF-beta 1 determinations
- timeFrame
- From baseline to up to 4 weeks
- description
- Blood specimens will be collected by venipuncture, before starting treatment, immediately after the last treatment fraction
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Post-menopausal women (at least 2 years without menstrual period): hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status. * Original tumor non-palpable (mammographically detected). * Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin). * N0 or sentinel node negative or N0 clinically if the tumor is \<1 cm in size. * Patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined. * Prescribed antihormonal therapy as part of their management. Exclusion Criteria: * Previous radiation therapy to the ipsilateral breast. * Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC). * Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination. * Women with a diagnosis of multifocal breast cancer.
References
Publications (1)
- RESULTFormenti SC, Hsu H, Fenton-Kerimian M, Roses D, Guth A, Jozsef G, Goldberg JD, Dewyngaert JK. Prone accelerated partial breast irradiation after breast-conserving surgery: five-year results of 100 patients. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):606-11. doi: 10.1016/j.ijrobp.2012.01.039. Epub 2012 Apr 9. PMID 22494589