The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.
Active, not recruiting
N/A
See points VIII inclusion/exclusion criteria
Operation:
- Lumpectomy, steninal node biopsy
- IOeRT
After Surgery:
- Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is
recommended as part of your treatment course. In some cases, pathology results may
indicate the need for removal of additional lymph nodes. The doctor will review
pathology and discuss if additional surgery is required.
- Chemotherapy (if indicated)
- Hormone therapy (if indicated)
Follow-Up
- Visits will be completed with the surgeon, radiation oncologist and research staff as
the protocol indicates.
- Assessements of acute toxicity according to CTC-toxicity scoring system
- Assessments of late toxicity according to LENT-SOMA scoring systems
- Assessment of cosmetic outcome according to scoring system and photo documentation in
standardized positions.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Single Fraction IOeRT | Experimental | A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered. |
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
- Post-menopausal women age > 60, defined as women who have experienced no menstrual
period in the past 12 months.
- 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 T1 (AJCC criteria)
- Grade 1, 2 acceptable
- Associated LCIS is allowed
- Estrogen receptor (ER) status of positive
- Negative margins at ink 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
Exclusion Criteria:
- Prior breast malignancy or other malignancy if metastatic, or with expected survival
of < 5 years
- Immuno-compromised 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
- Pure DCIS, all grades
- Invasive lobular carcinoma
- Evidence of lymphovascular invasion (LVI)
- Invasive carcinoma with extensive intraductal component (EIC)
- Neoadjuvant chemotherapy indicated
- Patients with 1 or more positive lymph node determined during surgery with sentinel
node and/or axillary dissection
- Not eligible for breast conserving management, i.e., prior whole breast radiation
therapy
- Estrogen receptor negative
- Her2 positive
- Grade 3
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 60 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
| Measure: | Proportion of patients who are free of breast cancer. |
| Time Frame: | 10 years |
| Safety Issue: | |
| Description: | Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated. |
| Measure: | Local recurrance rate with acute toxicity and cosmetic evaluations |
| Time Frame: | 10 years |
| Safety Issue: | |
| Description: | AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patients at 6-months follow-up, 4/20 patients at 1-year follow-up, 6/30 at 18-months follow-up, 8/40 at 24-months follow-up, 10/50 at 30-months follow-up, 12/60 at 36-months follow-up, 14/70 at 42-months follow-up, 16/80 at 48-months follow-up, 18/90 at 54-months and 20/100 at 60-months follow-up. Cosmetic evaluations will be completed by the patient and radiation oncologist an via breast exams, questionnaires and breast photo documentation. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Avera McKennan Hospital & University Health Center |
November 13, 2020
