Phase II - Preoperative Radiation followed by Lumpectomy. / Breast Cancer · Interventional Study

MRI-Based Preoperative Accelerated Partial Breast Irradiation

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an ongoing Phase II feasibility study examining preoperative accelerated partial breast irradiation (APBI) planned with MRI rather than conventional CT, followed by lumpectomy. No results are posted; the study remains active and not yet recruiting additional participants. The primary outcome is postoperative complications at 3 months.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Breast Cancer; Female; age from 40 Years. Intervention: Radiation Therapy followed by Lumpectomy. n = 39. 1 site: United States.

Key findings

Safety

No comparator arm; cannot assess benefit or harm relative to standard postoperative APBI or no radiation.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active, ongoing feasibility study with no results reported; it examines a novel sequencing of radiation and surgery with surrogate endpoints, representing early-phase exploratory work.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Postoperative Complications Following (assessed at 3 Months)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationBreast Cancer; Female; age from 40 Years

Sample size39

InterventionRadiation Therapy followed by Lumpectomy

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment39

Primary outcome measurePostoperative Complications Following, 3 Months

Study designSingle-arm, Phase II, interventional

Intervention sequencePreoperative APBI (3D-conformal external beam, MRI-planned) followed by lumpectomy at 5–8 weeks post-radiation

Caveats

No results are posted in this registry record; study status is active but not yet recruiting.
No comparator arm; cannot assess benefit or harm relative to standard postoperative APBI or no radiation.
Sample size justification and power calculation not reported.
Blinding, allocation method, and outcome assessment procedures not described in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Single-arm interventional feasibility study with defined primary outcome measure.

Directness

moderate

Directly examines feasibility of MRI-planned preoperative APBI; outcome is postoperative complications.

Consistency

insufficient

No comparator or comparison group described; single-arm design precludes consistency assessment.

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or outcome assessment methodology.

Sample adequacy

limited

Planned enrollment 39 participants; no sample size justification or power calculation stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT02728076). This is a study registration, not published results. Lead sponsor: Medical College of Wisconsin. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 39 participants (ACTUAL). Conditions: Breast Cancer. Interventions: RADIATION: Phase II - Preoperative Radiation followed by Lumpectomy.. Primary outcome measures: Postoperative Complications Following , 3 Months. Brief summary: This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT02728076Medical College of WisconsinPhase II - Preoperative Radiation followed by Lumpectomy.Breast Cancer