Single Fraction High-Gradient Partial Breast Irradiation in Treating Patients With Low-Risk Stage 0-I Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02076074|
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Radiation: accelerated partial breast irradiation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 2, 2014|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
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
- Proportion of patients who are free of serious treatment related toxicity [ Time Frame: Up to 5 years ]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 ]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 ]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 ]
- Quality of life [ Time Frame: Up to 5 years ]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 ]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 ]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 ]
- Presence of complications using CTCAE v. 4.0 [ Time Frame: Up to 5 years ]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 ]
- Proportion of patients undergoing mastectomy [ Time Frame: Up to 5 years ]The rate of mastectomy within five years of HG-PBI treatment will be calculated with a 95% confidence interval.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076074
|Contact: Imran Zoberi, M.D.||firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint 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|