Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
Running, not enrolling · Phase 2
Conditions studied: Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
In brief
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.
Key facts
- Study ID
- NCT02927912
- Run by
- Ohio State University Comprehensive Cancer Center
- People needed
- 108
- Starts
- 2017-10-16
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Pathologically proven diagnosis of breast cancer
- Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
- Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
- Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
- History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
- Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
- Absolute neutrophil count > 1800 cells/cubic mm
- Platelets >= 75,000 cells/cubic mm
- Hemoglobin >= 8 g/dL
- Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
- Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- Patients must provide study specific informed consent prior to study entry
You may not qualify if…
- Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
- Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
- Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
- Two or more cancers not resectable through a single lumpectomy incision
- Bilateral breast cancer
- Ductal breast carcinoma in situ (DCIS) only
- Non-epithelial breast malignancies such as sarcoma/lymphoma
- Male breast cancer
- Paget's disease of the nipple
- Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
- Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
Where it is running
- University of North Carolina — Chapel Hill, North Carolina, United States
- University Hospitals — Cleveland, Ohio, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- Avera Cancer Institute — Sioux Falls, South Dakota, United States
- Centre Hospitalier de I'Universite de Montreal — Québec, Montreal, Canada
Full record on ClinicalTrials.gov
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