Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning
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|ClinicalTrials.gov Identifier: NCT03340402|
Recruitment Status : Suspended (Slow Accrual)
First Posted : November 13, 2017
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Accelerated Partial Breast Irradiation Device: AlignRT||Not Applicable|
This research study is a Pilot Study, which means this is the first time investigators are examining this study intervention in participants with triple negative breast cancer.
The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for your specific disease but it has been approved for other uses.
The investigators believe that proton radiation administered in higher doses over a shorter time period may help stop cancer from growing while protecting the normal tissue cells.
In this research study, the investigators are researching how well proton radiation works in treating this type of breast cancer. Proton radiation is currently used in other types of breast cancer and the investigators believe that the higher doses of proton radiation administered over a shorter time period may lead to maximum efficacy in treating this type of breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning|
|Actual Study Start Date :||December 7, 2017|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2023|
Experimental: Accelerated Partial Breast Irradiation
Accelerated partial breast irradiation using proton beam scanning will consist of;
Radiation: Accelerated Partial Breast Irradiation
AlignRTTM uses infrared imaging to capture the 3D data of the patient's position to ensure accuracy of treatment delivery
- Cumulative incidence of grade ≥ 3 acute dermatitis [ Time Frame: 4 Months ]The number of participants that experience grade 3 or greater acute dermatitis as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4).
- The margins needed around Gross Tumor Volume (GTV) [ Time Frame: 4 Months ]Summary of the margins needed around gross tumor volume based on the true tumor location.
- Summary of treatment related adverse events [ Time Frame: 2 years ]Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
- Pathological response rate [ Time Frame: 2 years ]Evaluation of the extent of residual active tumor following radiation as assessed on the surgical pathology specimen
- Rates of local failure [ Time Frame: 2 years ]The number of participants with local recurrence of cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340402
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Rachel B Jimenez, MD||Massachusetts General Hospital|