Single Fraction High-Gradient Partial Breast Irradiation in Treating Patients With Low-Risk Stage 0-I Breast Cancer
This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a type of radiation therapy focused only to the part of the breast that has cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent breast cancer from coming back, and improve the appearance of the breast and quality of life of patients with breast cancer.
Radiation: accelerated partial breast irradiation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Single Fraction High-Gradient Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-Risk Stage 0 and I Breast Carcinoma|
- Proportion of patients who are free of serious treatment related toxicity [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity per CTCAE, version 4.0
- Proportion of patients who are free of breast cancer in the treated breast [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Rate of patients without ipsilateral breast tumor recurrences (IBTR). Calculated with a 95% confidence interval.
- Proportion of patients who are free of breast cancer in the regional lymph nodes [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups. Calculated with a 95% confidence interval.
- Proportion of patients who are free from distant metastases [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Measured by the EORTC QLQ-C30, QLQ-BR23, and the Visual Analog Scale for Pain. Each of the subscales will be tabulated and presented graphically over the assessment times. Mixed repeated measures models will be generated to describe the nature of change in quality of life over time.
- Cosmesis as measured quantitatively [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]BRA and pBRA scores are calculated. pBRA scores will be plotted at the assessment time points and presented graphically.
- Cosmesis as measured qualitatively [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Using the Aronson modified Harris scale. Assessed by patients and physicians. The two sets of scores will be plotted using histograms. Kappa statistics with 95% confidence intervals will be calculated to assess the agreement between patient and physician scores before treatment, at 4-6 months at 1 year, and at subsequent visits.
- Proportion of patients surviving [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Presence of complications using CTCAE v. 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Complications will be tabulated and frequencies presented graphically.
- Frequency of any grade 3-4 toxicities using CTCAE v4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Proportion of patients undergoing mastectomy [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The rate of mastectomy within five years of HG-PBI treatment will be calculated with a 95% confidence interval.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||April 2027|
|Estimated Primary Completion Date:||April 2022 (Final data collection date for primary outcome measure)|
Experimental: Treatment (HG-PBI)
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
Radiation: accelerated partial breast irradiation
Other Name: APBI
This is a phase I/II study which will evaluate the complication rates, local control, cosmetic results, and quality of life of single fraction high gradient partial breast irradiation (HG-PBI) when used as the sole method of radiation therapy for patients with pathologic stage 0 (=< 2 cm) or I carcinoma of the breast treated with partial mastectomy with histologically assessed negative surgical margins.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02076074
|Contact: Imran Zoberi, M.D.||firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Imran Zoberi, M.D. 314-362-8610 email@example.com|
|Sub-Investigator: Maria Thomas, M.D., Ph.D.|
|Sub-Investigator: Laura Ochoa, ANP, Ph.D.|
|Sub-Investigator: Rojano Kashani, Ph.D.|
|Sub-Investigator: Julie Margenthaler, M.D.|
|Sub-Investigator: Souzan Sanati, M.D.|
|Sub-Investigator: Todd DeWees, Ph.D.|
|Principal Investigator:||Imran Zoberi, M.D.||Washington University School of Medicine|