This trial is active, not recruiting.

Condition breast cancer
Treatments surgery, therapy, radiation therapy
Phase phase 2
Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date February 2003
End date September 2011
Trial size 89 participants
Trial identifier NCT00182728, CDR0000440120, LCCC 0218


RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Intraoperative radiation during surgery for tumor excision.
radiation therapy

Primary Outcomes

Rates of good/excellent cosmesis as measured by the RTOG cosmetic rating scale
time frame: 2 years
Incidence of grade 3/4 toxicity
time frame: 3 months
Association of nuclear p53 expression in tumor and normal tissue before and after IORT
time frame: 3 months
Association of nuclear NFkB expression in tumor and normal tissue before and after IORT
time frame: 3 months
Association of phosphorylated EGFR, HER2, p44/42 MAPK, and Akt in breast tumors and normal tissue before and after IORT
time frame: 3 months

Secondary Outcomes

Ipsilateral breast recurrence (tumor bed recurrence versus elsewhere in breast
time frame: 5 years

Eligibility Criteria

Female participants from 48 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed primary invasive ductal carcinoma of the breast - Tumor size ≤ 3 cm - No extensive intraductal component - Tumor must not be attached to the skin, underlying muscle, or chest wall - Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist - Tumor amenable to segmental mastectomy (i.e., lumpectomy) - No bilateral breast cancer - No clinical or radiographic multifocal disease not amenable to single segmental mastectomy - Patients with > 1 tumor mass in the same breast must have only 1 mass that is histologically malignant AND all other masses must be proven histologically benign - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 48 and over Sex - Female Menopausal status - Not specified Performance status - 0-2 Life expectancy - At least 5 years Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant - Fertile patients must use effective contraception - No collagen vascular disease - No medical condition that would preclude surgery - Other prior malignancy allowed provided the following criteria are met: - Patient has undergone potential curative therapy for all prior malignancies - There is no evidence of any prior malignancy within the past 5 years - Patient is deemed to be at low risk for recurrence of prior malignancy, as determined by the treating physician PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for this malignancy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the breast Surgery - No breast implants

Additional Information

Official title Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue
Principal investigator David Olilla, MD
Description OBJECTIVES: Primary - Determine the feasibility of intraoperative partial breast radiotherapy prior to surgical resection in older women with low-risk early stage primary invasive ductal carcinoma of the breast. - Determine the rate of good/excellent cosmesis, as measured by the RTOG cosmetic rating scale, in patients treated with this regimen. - Compare the cosmetic outcome in patients treated with this regimen with that of patients treated with partial breast brachytherapy in clinical trial RTOG-9517. - Determine the incidence of grade 3-4 toxicity of this regimen in these patients. - Determine the rate of ipsilateral breast recurrence, including recurrence within the tumor bed as compared to elsewhere in the breast, in patients treated with this regimen. Secondary - Determine the radiation-induced activation of receptors and signal transduction pathways involved in radiation response in patients treated with this regimen. OUTLINE: This is a non-randomized study. Patients undergo intraoperative lymphatic mapping and sentinel lymphadenectomy OR standard level I, II axillary dissection to evaluate the lymph nodes followed by intraoperative breast ultrasonography to define the tumor target volume. Patients then undergo intraoperative single-dose partial breast radiotherapy followed by segmental mastectomy (i.e., lumpectomy) of the tumor. Patients with 1 or 2 tumor-involved surgical margins may undergo repeat segmental mastectomy. Patients with > 2 tumor-involved surgical margins undergo mastectomy. Patients determined to have a tumor size > 3 cm or an extensive intraductal component on final pathology evaluation undergo standard external beam radiotherapy after surgery. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 to 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.