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Radiation Therapy

Accelerated Partial Breast Irradiation for Breast Cancer

N/A
Waitlist Available
Led By Frederick M. Dirbas
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ
Must not have
Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
Immunocompromised
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing different courses of radiation therapy to see which is most effective and safe for treating breast cancer.

Who is the study for?
This trial is for women aged 40 or older with invasive ductal carcinoma or ductal carcinoma in situ, choosing lumpectomy over mastectomy. The tumor must be smaller than 2.5 cm with a clear margin of normal tissue around it. It's not for those who are immunocompromised, pregnant, have poorly controlled diabetes, previous malignancies with less than five years survival expectation, certain breast implants, or contraindications to radiotherapy.
What is being tested?
The study tests if accelerated radiotherapy after lumpectomy is as safe and effective as the standard six-week course. Methods include IORT as a single dose; intracavitary brachytherapy over five days; partial breast 3-D CRT in five days; or stereotactic APBI across four days. Outcomes like treatment complications, cosmetic results, cancer recurrence rates and overall survival will be measured.
What are the potential side effects?
Potential side effects may include skin changes at the treatment site such as redness and irritation, fatigue due to radiation exposure, discomfort from the procedure itself and rare risks associated with radiation such as secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is smaller than 2.5 cm with a clear margin of normal tissue around it.
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I am a woman over 40 with a type of breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer was found in lymph nodes during my lumpectomy.
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My immune system is weak.
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My breast cancer is of the invasive lobular type.
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I am a man.
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I have had cancer before, but it was not spreading or expected to shorten my life by more than 5 years.
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My diabetes, which requires insulin, is not well-controlled.
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I cannot receive radiotherapy due to a condition like scleroderma.
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My breast cancer is present in more than one location.
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I have 1 to 3 lymph nodes with cancer found after surgery.
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My breast cancer has spread to my skin or chest wall.
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My breast cancer has a large area of growth within the milk ducts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 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
In-breast tumor recurrence (IBTR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Accelerated Partial Breast IrradiationExperimental Treatment5 Interventions
lumpectomy with accelerated partial breast irradiation
Group II: Standard TherapyActive Control2 Interventions
lumpectomy and whole breast irradiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumpectomy
2017
Completed Phase 2
~740

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,471 Previous Clinical Trials
17,501,598 Total Patients Enrolled
60 Trials studying Breast Cancer
110,649 Patients Enrolled for Breast Cancer
Frederick M. DirbasPrincipal InvestigatorStanford University
1 Previous Clinical Trials
1 Trials studying Breast Cancer

Media Library

Accelerated External Beam 3-D Conformal Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00185744 — N/A
Breast Cancer Research Study Groups: Standard Therapy, Accelerated Partial Breast Irradiation
Breast Cancer Clinical Trial 2023: Accelerated External Beam 3-D Conformal Radiotherapy Highlights & Side Effects. Trial Name: NCT00185744 — N/A
Accelerated External Beam 3-D Conformal Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00185744 — N/A
~64 spots leftby Mar 2029
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