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Radiation Therapy

IMRT vs. APBI for Early Stage Breast Cancer (2009-APBI Trial)

Phase 3
Recruiting
Led By Charles Leonard, MD
Research Sponsored by Rocky Mountain Cancer Centers
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
Must not have
Gross multifocal disease and microscopic disease greater than 3.0 cm.
Inadequate surgical margins ( < 0.2 cm) after final surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-15 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial shows that a new type of radiation therapy is effective and safe for treating breast cancer. It also spare more normal breast and lung tissue.

Who is the study for?
This trial is for early stage breast cancer patients who've had a lumpectomy with clear margins and no widespread disease. They must start radiotherapy within 10 weeks post-surgery, have localized disease confirmed by MRI, and be willing to follow the study's protocol.
What is being tested?
The trial compares two types of radiation therapy after lumpectomy: Intensity Modulated Radiotherapy (IMRT) versus standard 3D-conformal Accelerated Partial Breast Irradiation (APBI). It aims to see if IMRT better spares healthy tissue and improves outcomes.
What are the potential side effects?
Potential side effects include skin irritation, fatigue, changes in breast size or shape, pain or discomfort at the treatment site, and rare lung inflammation due to exposure during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had an MRI before my lumpectomy for DCIS.
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My cancer is small and confined, measuring 3.0 cm or less.
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My last surgery removed all the cancer with clear margins.
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My cancer is early stage and has not spread beyond its original site.
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I have markers placed in my body for radiation therapy that do not move.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has multiple visible tumors larger than 3.0 cm.
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My last surgery didn’t remove all the cancer, leaving some very close to the edge of what was taken out.
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I have persistent cancerous or suspicious calcium deposits.
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I have a collagen-vascular disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
Secondary study objectives
Acute skin reactions
Cause specific survival
Cosmetic outcomes after APBI
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IMRTExperimental Treatment1 Intervention
Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days
Group II: 3D-CRTActive Control1 Intervention
Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days

Find a Location

Who is running the clinical trial?

Rocky Mountain Cancer CentersLead Sponsor
7 Previous Clinical Trials
849 Total Patients Enrolled
1 Trials studying Breast Cancer
291 Patients Enrolled for Breast Cancer
Charles Leonard, MDPrincipal InvestigatorRocky Mountain Cancer Centers
1 Previous Clinical Trials

Media Library

Accelerated Partial Breast Irradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01185132 — Phase 3
Breast Cancer Research Study Groups: IMRT, 3D-CRT
Breast Cancer Clinical Trial 2023: Accelerated Partial Breast Irradiation Highlights & Side Effects. Trial Name: NCT01185132 — Phase 3
Accelerated Partial Breast Irradiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01185132 — Phase 3
~40 spots leftby Dec 2025
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