Phase 3
Completed N=520
Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
Source: ClinicalTrials.gov NCT02104895 ↗Enrolled (actual)
520
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Ipsilateral Breast Tumor Recurrence — 1.4; 1.5 percentage of participants
◆ Published Evidence
Highly cited
463citations · ~42 / year
Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial.
Summary
The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.
Linked Publications (5)
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Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial.
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Accelerated partial breast irradiation with IMRT: new technical approach and interim analysis of acute toxicity in a phase III randomized clinical trial.
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Accelerated partial breast irradiation using intensity-modulated radiotherapy technique compared to whole breast irradiation for patients aged 70 years or older: subgroup analysis from a randomized phase 3 trial.
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Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial.
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External accelerated partial breast irradiation for ductal carcinoma in situ: long-term follow-up from a phase 3 randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ipsilateral Breast Tumor Recurrence |
1.4; 1.5 | — |
| SECONDARY Acute Skin Toxicity |
37.7; 2 | — |
| SECONDARY Excellent Cosmesis |
89.6; 95.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age at presentation >40 y
- Tumor size 5 mm)
- Clips placed in tumor bed
- Full informed consent from patient
Exclusion Criteria
- Cardiac dysfunction
- Forced expiratory volume in 1 second (FEV1) <1 L/m
- Extensive intraductal carcinoma
- Multifocal cancer
- Psychiatric problems
- Recurrent breast cancer
Data sourced from ClinicalTrials.gov (NCT02104895) and the linked publication. 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.