IMRT vs 3D-Conformal Radiation for Early Stage Breast Cancer
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
660 (estimated)
Sponsor
Rocky Mountain Cancer Centers · Other
Who this trial is looking for
This trial is looking for women with early stage breast cancer who have had a lumpectomy. Participants will receive either a new type of radiation therapy or a standard one to see which works better and is safer.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with early stage breast cancer.
I have had a lumpectomy.
I have clear surgical margins after my surgery.
I have had an MRI scan of my breast before surgery.
I am willing to undergo additional screening.
You may not be able to join if
I am pregnant or breastfeeding.
I have collagen-vascular disease.
I have unclear surgical margins after my surgery.
I have persistent suspicious micro-calcifications.
I have large areas of cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 w…
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.
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