Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02400658
• Other study ID #: 18004
• Secondary ID: IORT2
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 2027

Study information

• Verified date: January 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

Description:

This is a prospective single-arm phase II study designed to study the efficacy of high dose rate (HDR) brachytherapy with CT-imaging, single-fraction intraoperative radiation therapy (IORT). The study will accrue patients with early-stage breast cancer who will be treated with breast-conserving surgery (BCS). The main clinical eligibility criterion is based on suitability for accelerated partial breast irradiation. Patients may be eligible prior to receiving BCS or within 30 days of receiving BCS. Eligible patients that will undergo BCS will receive surgery according to the standard clinical practice in the Brachytherapy Suite in the Emily Couric Clinical Cancer Center. Patients that have already undergone BCS must meet all other eligibility criteria and are able to be treated with IORT within 30 days of their breast surgery. Eligible subjects will undergo a lumpectomy or re-excision lumpectomy according the standard clinical practice. Immediately following lumpectomy, the breast HDR brachytherapy applicator will be placed and CT imaging will be performed for treatment planning. After HDR brachytherapy is delivered, the applicator will be removed, and the breast surgeon will complete the skin closure. Although the ultimate goal of the study is to determine 5-year ipsilateral breast tumor recurrence (IBTR), all efforts will be made to follow the patients until death.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 358
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.

2. Tumor size must be less than or equal to 3 cm.

3. Patient is 45 years of age or older.

Exclusion Criteria:

1. Male patients.

2. Pregnant patients.

3. Breast cancer that involves the skin or chest wall.

4. History of ipsilateral breast cancer.

5. Multicentric breast cancer in the ipsilateral breast.

6. Known BRCA gene mutation.

7. Patient with nodal disease.

8. Patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size.

9. Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• IORT with CT-Guided HDR Brachytherapy
This therapy targets the cancer cells directly, reducing the volume of breast tissue exposed to the radiation and the risks involved with the radiation. CT imaging will be used via a multichannel/multi-dwell balloon catheter to better sculpt the cancer away from the heart, skin, and ribs.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Hackensack Meridian Health - John Theurer Cancer Center	Hackensack	New Jersey
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shayna Showalter, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Local Breast Tumor Recurrence		Up to 60 Months After Treatment
Secondary	Rate of Ipsilateral Breast Tumor (Not Local) Recurrence		Up to 60 Months After Treatment
Secondary	Rate of Distant Recurrence of Breast Cancer		Up to 60 Months After Treatment
Secondary	Cancer Specific-Survival and Overall Survival Response Rate		Minimum of 60 Months After Treatment
Secondary	Changes in Reported Patient and Physician Cosmetic Descriptions		Up to 60 Months After Treatment
Secondary	Comparison of Pre-and Post Pathology Stratum		Up to 60 Months After Treatment
Secondary	Changes in Patient-Reported Quality of Life		Up to 60 Months After Treatment
Secondary	Number of Participants with Adverse Events	Safety and toxicity of treatment will be determined with the Common Toxicity Criteria for Adverse Effects.	24 Months After Treatment
Secondary	Changes of Radiographic Breast Appearance		Up to 60 Months After Treatment