Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01203839|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2010
Last Update Posted : September 24, 2018
Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast.
However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI.
WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks.
In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: multiple beams utilizing either intensity-modulated or 3D-conformal techniques||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer|
|Actual Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Radiation treatment
This is a Phase II single-arm study of PBI with external-beam radiation therapy in which a group of select women with early-stage invasive and noninvasive breast cancer will be given radiation to the partial breast.
Radiation: multiple beams utilizing either intensity-modulated or 3D-conformal techniques
A dose of 40 Gy will be delivered to the tumor bed plus 1.5-2 cm margin. Treatment will be delivered once daily, 5 days a week, for approximately 2 weeks. Radiation therapy will begin within a minimum of 4 weeks and a maximum of 3 months from definitive surgical procedure and 2-6 weeks after chemotherapy, if chemotherapy given first. Prior to radiation, patients will receive a lumpectomy with an assessment of axillary lymph node status (for invasive tumors only). Axillary assessment may be any combination of sentinel lymph node biopsy or axillary lymph node dissection.
- To evaluate the safety of PBI-directed external-beam radiation therapy [ Time Frame: Two weeks ]In selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions for two weeks.
- To evaluate local control rates [ Time Frame: 1 year ](local control for patients with DCIS will be analyzed separately from those patients with invasive cancer)
- To evaluate distant control rates [ Time Frame: 1 year ]
- To evaluate breast cosmesis [ Time Frame: 1 year ]
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): NCT01203839
|United States, New Jersey|
|Memorial Sloan Kettering at Basking Ridge (Follow-up Only)|
|Basking Ridge, New Jersey, United States, 07920|
|Memoral Sloan Kettering Monmouth (Follow-up Only)|
|Middletown, New Jersey, United States, 07748|
|Memorial Sloan Kettering Bergen (Follow-up Only)|
|Montvale, New Jersey, United States, 07645|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk (Follow-up Only)|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester (Follow-up Only)|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center (Follow-up Only)|
|Rockville Centre, New York, United States|
|Principal Investigator:||Simon Powell, MD||Memorial Sloan Kettering Cancer Center|