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IMRT vs. 3D-conformal APBI for Early Stage Breast Cancer

This study is comparing two types of radiation therapy for early-stage breast cancer after a lumpectomy (surgery to remove a tumor while saving the breast). It's looking at Intensity Modulated Radiotherapy (IMRT) and 3D-conformal Accelerated Partial Breast Irradiation (APBI). Both treatments deliver 38.5 Gy of radiation in 10 sessions over 5 days. Researchers want to see if IMRT, which may spare more healthy tissue, leads to less breast or chest wall pain compared to 3D-conformal APBI. You might be able to join if you are at least 40 years old, have early-stage breast cancer (Tis, T1, T2 up to 3.0 cm, N0, M0), and have clear surgical margins (at least 0.2 cm). The study aims to enroll 660 participants.

Study design
This interventional study plans to enroll 660 participants to compare two radiation treatments. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for breast pain for up to 5 years and for chest wall pain for 2 to 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01185132

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

Recruiting
PHASE3Ages 40+InterventionalTreatment
Rocky Mountain Cancer Centers
~660 participants
Updated 2014-06-26 on ClinicalTrials.gov
What's tested:accelerated partial breast irradiation - 3D-conformal planningaccelerated partial breast irradiation - IMRT planning

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Measured over 5 years
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaBreast Ductal Carcinoma In Situ

Where it's being run

5 sites across 1 states
Colorado5

Study leadership

  • Charles Leonard, MD · PRINCIPAL_INVESTIGATOR · Rocky Mountain Cancer Centers

Who to contact

Rachel Lei, BS
[email protected]
303-418-7607
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)5 years

    Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit

  • Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)2-5 years

    Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit