What is the mechanism of action of this treatment?

Breast cancer treatments commonly include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. The Xoft Axxent eBx System, a form of single-fraction intraoperative radiation therapy (IORT), delivers a concentrated dose of radiation directly to the tumor bed during surgery, targeting residual cancer cells while sparing surrounding healthy tissue. This approach reduces the overall treatment time and minimizes radiation exposure to non-cancerous tissues. Understanding these mechanisms is crucial for breast cancer patients as it helps them make informed decisions about their treatment options, balancing efficacy with potential side effects and quality of life considerations.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as breast-conserving surgery combined with radiation therapy, can have several side effects. Radiation therapy may cause skin irritation, fatigue, breast pain, and swelling. Long-term effects can include changes in breast shape and texture, and in rare cases, heart or lung problems. Chemotherapy, often used alongside radiation, can lead to hair loss, nausea, fatigue, increased risk of infection, and neuropathy. Single-fraction intraoperative radiation therapy (IORT) like the Xoft Axxent eBx System aims to minimize some of these side effects by delivering a concentrated dose of radiation during surgery, potentially reducing the overall treatment time and exposure to surrounding healthy tissues.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, including various forms of radiation therapy. One notable approval is for intraoperative radiation therapy (IORT), which delivers a concentrated dose of radiation to a tumor site immediately after surgical removal of the tumor. This approach is similar to the Xoft Axxent eBx System being studied. IORT aims to target residual cancer cells while minimizing exposure to surrounding healthy tissue. Other FDA-approved treatments for breast cancer include external beam radiation therapy (EBRT) and systemic therapies such as chemotherapy, hormone therapy, and targeted therapies like trastuzumab and pertuzumab.

What other types of research exist?

Promising novel alternatives to the Xoft Axxent eBx System for breast cancer patients include: 1) Proton therapy, which offers precise targeting of tumors with minimal damage to surrounding tissues. 2) Hypofractionated radiation therapy, which delivers higher doses of radiation over fewer sessions, reducing treatment time. 3) Stereotactic body radiation therapy (SBRT), which provides high-dose radiation with pinpoint accuracy, suitable for small, well-defined tumors. These alternatives have shown efficacy in recent studies and may offer improved outcomes for breast cancer patients.

← Back to Search

Brachytherapy

Intra-operative Radiation Therapy for Breast Cancer

N/A

Waitlist Available

Led By Helena Chang, MD, PhD

Research Sponsored by Xoft, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast

Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0

Must not have

Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer

Subject has known lympho-vascular invasion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline reported at 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device that gives a single dose of radiation during breast cancer surgery. It targets women with early-stage breast cancer to see if it works as well as the usual longer radiation treatments. The goal is to make treatment quicker and easier while still being effective.

Who is the study for?

This trial is for women over 40 with early-stage breast cancer (ductal carcinoma) that's less than 3 cm in size. They must not be pregnant or nursing, agree to use birth control, and have no history of certain breast cancers or treatments like chemotherapy before surgery. Women with pacemakers near the treatment area or autoimmune diseases can't join.

What is being tested?

The study tests the Xoft Axxent eBx System for single-fraction IORT as a stand-alone radiation therapy compared to whole breast irradiation in treating early stage breast cancer during conserving therapy.

What are the potential side effects?

While specific side effects are not listed here, typical risks of intra-operative radiation therapy may include skin irritation, pain at the site, fatigue, and potential complications related to exposure of nearby tissues and organs to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a type of breast cancer.

Select...

My cancer is early stage and the tumor is small.

Select...

My tumor is smaller than 3.0 cm in size.

Select...

I am a woman aged 40 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have received initial treatment with chemotherapy or hormone therapy for my current breast cancer.

Select...

My cancer has spread to my lymph system or blood vessels.

Select...

I have invasive lobular cancer.

Select...

I cannot undergo radiation therapy due to health risks.

Select...

My breast cancer has come back in the same breast.

Select...

I have breast cancer in more than one location in the same breast.

Select...

My affected breast has been exposed to radiation before.

Select...

I have a pacemaker near where my breast cancer is located.

Select...

I have been diagnosed with breast cancer in more than one area through a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on-going monitoring, report at 5 and 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on-going monitoring, report at 5 and 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and on-going monitoring, report at 5 and 10 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

Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years

Secondary study objectives

Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 10 years

Assess the rate of regional breast tumor recurrence (RBTR)

Assess the safety of single fraction IORT at the time of breast conserving surgery for early stage breast cancer

+3 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: Intra-operative Radiation Therapy - IORTExperimental Treatment1 Intervention

Intra-operative Radiation Therapy

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments commonly include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. The Xoft Axxent eBx System, a form of single-fraction intraoperative radiation therapy (IORT), delivers a concentrated dose of radiation directly to the tumor bed during surgery, targeting residual cancer cells while sparing surrounding healthy tissue. This approach reduces the overall treatment time and minimizes radiation exposure to non-cancerous tissues. Understanding these mechanisms is crucial for breast cancer patients as it helps them make informed decisions about their treatment options, balancing efficacy with potential side effects and quality of life considerations.

St. Gallen/Vienna 2017: A Brief Summary of the Consensus Discussion about Escalation and De-Escalation of Primary Breast Cancer Treatment.Factors influencing treatment patterns of breast cancer patients age 75 and older.