An observational study in Breast Cancer, sponsored by Mount Carmel Health System. Recruiting at 1 site in United States. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Mount Carmel Health System · Observational
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.
Women aged 65 and above with early stage breast cancer, ER+, low to intermediate grade invasive ductal carcinoma of the breast amenable to breast conserving surgery and radiation therapy.
Exclusion Criteria:
All patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years.
Radiation: IORT
Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy
In-Breast Tumor Recurrence (IBTR)
Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
Time frame: 5 years
Late Toxicity
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
Time frame: 5 years
Acute Toxicity
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)
Time frame: 3 months
Disease Free Survival
Disease Free Survival
Time frame: 5 yeras
Overall Survival
Overall Survival
Time frame: 5 years
Plan to share: No
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