Clinical trial NCT02400658: Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
early-stage
IORT
brachytherapy
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 358
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of Local Breast Tumor Recurrence
timeFrame: Up to 60 Months After Treatment
Secondary outcomes:
measure: Rate of Ipsilateral Breast Tumor (Not Local) Recurrence
timeFrame: Up to 60 Months After Treatment
measure: Rate of Distant Recurrence of Breast Cancer
timeFrame: Up to 60 Months After Treatment
measure: Cancer Specific-Survival and Overall Survival Response Rate
timeFrame: Minimum of 60 Months After Treatment
measure: Changes in Reported Patient and Physician Cosmetic Descriptions
timeFrame: Up to 60 Months After Treatment
measure: Comparison of Pre-and Post Pathology Stratum
timeFrame: Up to 60 Months After Treatment
measure: Changes in Patient-Reported Quality of Life
timeFrame: Up to 60 Months After Treatment
measure: Number of Participants with Adverse Events
timeFrame: 24 Months After Treatment
measure: Changes of Radiographic Breast Appearance
timeFrame: Up to 60 Months After Treatment
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Meridian Health - John Theurer Cancer Center
state: New Jersey
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Shayna Showalter
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meneveau MO, Petroni GR, Varhegyi NE, Hulse JC, Schroen AT, Brenin DR, Janowski EM, Berger AC, Lazar MA, Simone NL, Showalter TN, Showalter SL. Toxicity and cosmetic outcomes after treatment with a novel form of breast IORT. Brachytherapy. 2020 Sep-Oct;19(5):679-684. doi: 10.1016/j.brachy.2020.05.002. Epub 2020 Jun 20.