Recruiting

Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

ClinicalTrials.gov IDNCT01185132
PhasePHASE3
Enrollment660
SponsorRocky Mountain Cancer Centers
Age40 Years
SexALL
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Conditions studied

Breast Cancer

About this study

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0. * Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less. * Negative surgical margins ( ≥ 0.2 cm) after final surgery. * Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease. * Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy. * Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease. * Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications. * Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4. * Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials. * PTV to ipsilateral breast ratio (IBR) ≤ 25 %. * Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins. Exclusion Criteria: * Pregnancy or breast-feeding. * Have collagen-vascular disease. * Inadequate surgical margins ( \< 0.2 cm) after final surgery. * Subjects with persistent malignant/suspicious micro-calcifications. * Gross multifocal disease and microscopic disease greater than 3.0 cm.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.