Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares two ways to give radiation to part of the breast: IMRT and standard 3D-conformal radiation. It is for people with early-stage breast cancer after a lumpectomy, surgery to remove the cancer. The study tests whether IMRT is safe and effective and protects more healthy breast and lung tissue.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have breast cancer confirmed by a tissue test, no larger than 3 cm, with no spread to lymph nodes or distant body parts.
- If there is more than one cancer spot seen only under a microscope, all spots together must span 3 cm or less.
- Have at least 2 mm of cancer-free tissue around the removed cancer after the final surgery.
- Have required breast MRI scans for certain cancer types. For DCIS, cancer inside the milk ducts, the MRI must be done before lumpectomy. Suspicious MRI findings need more tests.
- If a mammogram showed cancer-related calcium spots, have another mammogram after surgery to check that all were removed.
- Be willing to complete extra screening and meet the study's other eligibility rules.
- Have markers placed successfully that stay in place to guide radiation. The planned treatment area must be no more than 25% of the treated breast.
- Expect to start radiation within 10 weeks after lumpectomy or another surgery to remove tissue at its edges.
Who can't join
- Are pregnant or breastfeeding.
- Have collagen-vascular disease, a condition affecting the body's connective tissues.
- Have less than 2 mm of cancer-free tissue around the removed cancer after the final surgery.
- Still have tiny calcium spots that are cancerous or suspicious for cancer.
- Have multiple cancer spots visible without a microscope, or spots seen only under a microscope that span more than 3 cm.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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 sites (5)
CO
- Rocky Mountain Cancer Centers - Aurora · Aurora, CO 80012Dennis Carter, MD · Sub-investigatorWilliam Daniel, MD · Sub-investigatorKathryn Howell, MD · Sub-investigatorMore trials in Aurora
- Rocky Mountain Cancer Centers - Boulder · Boulder, CO 80303Andrew Antell, MD · Sub-investigatorMeera Patel, MD · Sub-investigatorRalph Wright, MD · Sub-investigatorMore trials in Boulder
- Rocky Mountain Cancer Centers - Lakewood · Lakewood, CO 80228Ralph Wright, MD · Sub-investigatorCharles Leonard, MD · Principal investigatorMore trials in Lakewood
- Rocky Mountain Cancer Centers - Littleton · Littleton, CO 80120Charles Leonard, MD · Principal investigatorKathryn Howell, MD · Sub-investigatorMore trials in Littleton
- Rocky Mountain Cancer Centers - Thornton · Thornton, CO 80260Robert LaPorte, MD · Sub-investigatorDaniel Chin, MD · Sub-investigatorMore trials in Thornton