Clinical trial NCT01960803: Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
Official title: Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Invasive Ductal Breast Cancer
Carcinoma Breast Stage I
Keywords: Stage I Breast Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

Detailed description: Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.

Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.

Eligibility criteria: Inclusion Criteria:

* Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
* Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
* Peri or post-menopausal women age \> 50, defined as women who have experienced no menstrual period in the past 6 months or more
* BRCA1 and 2 gene mutation negative, if tested. \[genetic testing is NOT required based upon personal or family history\]
* Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria)
* Grade 1, 2, or 3 acceptable
* Associated LCIS is allowed
* Pure DCIS allowed if \<2.5 cm, low to intermediate nuclear grade and resected margins negative at \> 3 mm (per ASTRO criteria)
* Estrogen receptor (ER) status of positive
* Patient has clear margins \>2 mm on gross pathologic examination
* Patient is node-negative, defined as N0 (i-) or N0 (i+)
* Patient must be deemed functionally and mentally competent to understand and sign the informed consent
* Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy

Exclusion Criteria:

* Prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years
* Immunocompromised status
* Pregnancy
* Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
* Breast cancer that involves the skin or chest wall, locally advanced breast cancer
* Invasive lobular carcinoma
* Evidence of lymphovascular invasion (LVI)
* Invasive carcinoma with extensive intraductal component (EIC)
* Neoadjuvant chemotherapy
* Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
* Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy

Primary outcomes:
measure: To evaluate change over time on the incidence of local and distance recurrence rates.
timeFrame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
Secondary outcomes:
measure: To evaluate changes in the short-term and long-term side effects related to IOERT
timeFrame: 1 month, 3 months, 6 months, 12 months, and then annually for 10 years.
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
Study officials:
affiliation: Advocate Health Care - Advocate Christ Medical Center
name: Barbara Krueger, MD FACS
role: PRINCIPAL_INVESTIGATOR
References: