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Active Not Recruiting
NCT02927912
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
Conditions: Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 108
Sponsor: Ohio State University Comprehensive Cancer Center
Location: University of North Carolina Chapel Hill North Carolina
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT02927912). StuddyBuddy aggregates publicly available trial information.