Breast Cancer
Conditions
Keywords
breast cancer, invasive ductal carcinoma, intraoperative radiation therapy, iort
Brief summary
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
Interventions
RADIATIONIORT
Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy
Sponsors
Mount Carmel Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * ECOG performance status 0-1 * Age 65 years or older * cT1 or cT2 (≤3.0 cm) * Invasive ductal carcinoma histology * Estrogen receptor positive (ER+) * Grade 1 or Grade 2 * Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling * Suitable for breast conserving surgery and radiation therapy * Patient must be able to provide study-specific informed consent
Exclusion criteria
* Multi-centric cancer not amenable to single lumpectomy * Prior ipsilateral whole breast radiation * Known BRCA 1 or BRCA 2 mutation * Status post neoadjuvant hormonal or chemotherapy * Invasive lobular histology * Pure ductal carcinoma in situ (DCIS) * Grade 3 * Diffuse suspicious microcalcifications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-Breast Tumor Recurrence (IBTR) | 5 years | Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Toxicity | 5 years | Degree of late radiation toxicity will be scored based upon RTOG/EORTC (Radiation Therapy Oncology Group/Eastern Oncology Radiation Therapy Consortium) late radiation morbidity scoring schema for subcutaneous tissue as well as cosmetic result. The RTOG/EORTC late radiation morbidity scoring schema on subcutaneous tissue is as follows: * GRADE 1: Slight induration (fibrosis) and loss of subcutaneous fat * GRADE 2: Moderate fibrosis but asymptomatic; slight field contracture; \<10% linear reduction * GRADE 3: Severe induration and loss of subcutaneous tissue; field contracture \> 10% linear measurement * GRADE 4: Necrosis |
| Acute Toxicity | 3 months | Acute radiation toxicity will be scored at the first follow-up visit after IORT (4-6 weeks after treatment). Radiation dermatitis will be scored based upon CTCAE (Common Terminology Criteria for Adverse Events) v4.03 scale as follows: * GRADE 1: Faint erythema or dry desquamation * GRADE 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema * GRADE 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion * GRADE 4: Life threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated Other acute toxicity will also be scored per the CTCAE v4.03 scale and will be rated on the relation to radiation therapy (definitely related, probably related, possibly related, unlikely related, unrelated) |
| Disease Free Survival | 5 yeras | Disease Free Survival |
| Overall Survival | 5 years | Overall Survival |
Countries
United States
Contacts
Primary ContactLynn Shaffer, PhD
Outcome results
None listed