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.
Completed
N/A
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| IOERT arm | Experimental | Intraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes. |
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
| Maximum Eligible Age: | 95 Years |
| Minimum Eligible Age: | 50 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
| Measure: | To evaluate change over time on the incidence of local and distance recurrence rates. |
| Time Frame: | 1 month, 3 months, 6 months, 12 months, and then annually for 10 years. |
| Safety Issue: | |
| Description: | Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol. |
| Measure: | To evaluate changes in the short-term and long-term side effects related to IOERT |
| Time Frame: | 1 month, 3 months, 6 months, 12 months, and then annually for 10 years. |
| Safety Issue: | |
| Description: | Assessment of the overall patient satisfaction related to the therapy and cosmetic outcome. Cosmesis will be scored by both the physician and patient using the RTOG cosmesis rating system at one month, three months, six months, twelve months, and 24 months. The secondary outcome measure will only take place in the first two years of the 10 year time frame for patient follow up. After 24 month evaluations, patients will only be followed for incidence of local and distance recurrence rates. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Advocate Health Care |
July 24, 2019
