Clinical trial · Observational
Accelerated Partial Irradiation of the Breast: New Altered Fractionation
NCT04101656CI-TRIAL-00071159unknownClinicalTrials.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 aim of this observational study is to evaluate a dose fractionation scheme for APBI using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality of life of patients as it decreases the treatment number of sessions and improves the efficiency and accessibility.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Experimental: APBI (Accelerated Partial Breast Irradiation)
- description
- APBI 28 Gy in 5 fractions of 5.6 Gy, using external radiotherapy with modulated intensity technique (IMRT)
Primary outcomes (1)
- measure
- Evaluate the security in terms of acute toxicity
- timeFrame
- Up to 5 years after the end of the irradiation
- description
- Adverse effects due to radiotherapy
Secondary outcomes (5)
- measure
- Dose analysis in critical organs
- timeFrame
- Up to 5 years after the end of the irradiation
- description
- Measurement of dose in the heart, ipsilateral and contralateral lung, ipsilateral and contralateral breast taking into account the acceptable and optimal dose limit.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 45 years or 40-44 if there isn´t any other risk factor * Diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) and that have undergone conservative surgery without ganglionar involvement (pN0) of any histological degree except from invasive lobular carcinoma and with a size ≤ 3 cm. * Disease free margins (R0: \> 2mm). * Positive and negative estrogen receptor tumors. Exclusion Criteria: * Multicentric and multifocal tumors, except from if it´s focal and the only risk factor. * Patients must not have undergone a neoadjuvant QT therapy. * Patients with BRCA positive mutation will be excluded. * Those patients unable or unsuitable to understand and accept the informed consent. * Metastasic´s affectation evidence. * Extensive lymphovascular invasion, except from if the total resulting size of the focus and breast parenchyma addition is ≤ 3cm. * Breast implants presence in the breast that´s going to be treated. * Contraindicated radiotherapy treatment due to a diagnosis of cutaneous lupus, pregnancy or scleroderma. * Inability to fully know the dosimetric data of the APBI plan.
References
Publications (0)
Data not yet available
No reference posted for this study.