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Brachytherapy

Intraoperative Radiation Therapy for Breast Cancer

N/A
Recruiting
Led By Michael Alvarado, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suitable for breast conserving surgery
T1 and T2 (< 3.5 cm), N0, M0
Must not have
Synchronous bilateral breast cancer at the time of diagnosis
Axillary lymph node positive breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to give radiation therapy for breast cancer that may be as effective as the standard way, and has fewer side effects.

Who is the study for?
This trial is for individuals with early stage breast cancer (T1 and T2, no larger than 3.5 cm, no spread to lymph nodes or other parts of the body) who are suitable for breast-conserving surgery. It's not open to those under 50, with tumors over 3 cm, estrogen receptor negative cancers, HER2 positive status, high-grade tumors or extensive intraductal component.
What is being tested?
The study is testing intraoperative radiation therapy given one time during surgery where the tumor was removed. The goal is to see if this method can effectively kill any remaining tumor cells and compare its effectiveness against standard radiation treatments in patients with early-stage breast cancer.
What are the potential side effects?
While specific side effects aren't listed here, intraoperative radiation therapy could potentially cause skin irritation at the treatment site, fatigue similar to traditional radiation therapy effects and may have risks associated with surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a candidate for surgery that will not remove my entire breast.
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My cancer is small (under 3.5 cm) and has not spread to lymph nodes or other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was diagnosed with cancer in both breasts at the same time.
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My breast cancer has spread to the lymph nodes under my arm.
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I have a known BRCA1 or BRCA2 gene mutation.
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My cancer is HER2 positive.
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My tumor is larger than 3 cm.
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My cancer has spread to my lymph nodes.
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I have had chemotherapy or hormone therapy before.
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My cancer is not driven by estrogen.
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I am under 50 years old.
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My same breast had cancer before or received radiation.
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I have multiple cancer areas in one breast, not removable by one surgery.
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My breast cancer surgery showed more than 25% of the tissue had non-invasive cancer.
Select...
My tumor is larger than 3.5 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Frequency of site of relapse within the breast
Incidence of local recurrence
Median Overall Survival
+2 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (IORT)Experimental Treatment2 Interventions
Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intraoperative Radiation Therapy
2012
N/A
~500

Find a Location

Who is running the clinical trial?

Carl Zeiss Meditec AGIndustry Sponsor
42 Previous Clinical Trials
6,498 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,886,450 Total Patients Enrolled
46 Trials studying Breast Cancer
3,828,428 Patients Enrolled for Breast Cancer
Michael Alvarado, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Intraoperative Radiation Therapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01570998 — N/A
Breast Cancer Research Study Groups: Treatment (IORT)
Breast Cancer Clinical Trial 2023: Intraoperative Radiation Therapy Highlights & Side Effects. Trial Name: NCT01570998 — N/A
Intraoperative Radiation Therapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01570998 — N/A
~289 spots leftby Dec 2027
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