This trial is currently seeking participants
Researchers seek women with stage 0, I or II breast cancer who had lumpectomies to participate in a clinical trial that analyzes the safety and effectiveness of a more rapid course of radiation therapy against the standard treatment.
The ongoing randomized phase III trial compares the standard radiation therapy of 5 - 6 weeks to a 3-week course of adjuvant whole-breast irradiation (radiation to the whole breast), with a sequential boost (an additional dose) of radiation given daily to the area where the tumor was removed.
Study Background and Goals
After having a lumpectomy, women with early-stage breast cancer often receive radiation therapy to the area of the breast where the tumor was located. Previous studies showed that whole-breast radiation helps prevent breast cancer recurrence and reduces the chance of death.
The goal of this study is to find out whether a more rapid, 3-week course of radiation therapy is as safe and effective as the current standard. The investigators also hope that the shortened 3 weeks will allow more women to undergo this type of therapy.
Some women in the United States do not receive radiation therapy because they cannot commit to the length of treatment. Radiation treatment is typically given 5 days a week for 5 or more weeks, followed by a sequential boost for another 5 to 7 days.
“There’s already data showing that 3 weeks of radiation is as effective as 5 weeks, but that’s in a more select group of patients,” Frank A. Vicini, MD, of Radiation Therapy Oncology Group explains in a National Cancer Institute bulletin. “So, this study really has the potential to change the standard of care for the average woman with breast cancer.”
Structure of the Study
Participants are randomly assigned to one of two treatment groups.One group will receive radiation to the whole breast consisting of intensity-modulated radiation therapy (IMRT) or three-dimensional conformal radiotherapy (3D-CRT) for 5 days a week for 3 - 5 weeks followed by an additional boost to the site of the lumpectomy for 5 days a week for 1 to 1-and-a-half weeks in the absence of disease progression or difficulty with side effects.
Participants in the other treatment group receive more a rapid radiation therapy to the whole breast consisting of IMRT or 3D-CRT with an additional round of radiation to the lumpectomy area 5 days a week for 3 weeks in the absence of disease progression or difficulty with side effects.
Womens’ tissue samples may be collected for future research studies. After completing treatment, researchers follow up with participants after 1 month, at 6 months and then yearly.
You may be eligible to participate in this study if you:
- Have a diagnosis of stage I or II breast cancer removed by lumpectomy and plan to receive whole-breast radiation therapy with boost, without radiation to the lymph nodes around the breast
- Have stage I or II breast cancer and either: are under age 50; the cancer tested negative for estrogen- and progesterone-receptor sensitivity; or the tumor is high grade, meaning the cancer cells look very abnormal
- Have a high grade stage 0 (DCIS) breast cancer and are under age 50 (or are under age 50 with either no DCIS or no DCIS with a low grade)
- Received a lumpectomy as your maintreatment after systemic therapy
- Had a lumpectomy with either negative margins (no tumor at the surgically removed edge) or close surgical margins (greater than 0 but less than 2 mm)
- Have no evidence of stage IV disease
- Had mammography of either or both breasts within 90 days before neoadjuvant (before surgery) chemotherapy, a biopsy establishing diagnosis or last surgery (breast or axilla)
- Have no invasive breast cancer andare at low risk for breast cancer recurrence in 5 years after lumpectomy with negative margins
- Have no suspicious microcalcifications, densities or abnormalities remaining in your breast that can be felt unless biopsy proved them benign
- Have no Paget’s disease of the nipple
- Are female and 18 years of age or older
To learn more about eligibility, please talk with your doctor and visit the trial's page on ClinicalTrials.gov.
This study is being carried out at 276 locations in the United States and Canada. For a full listing of locations near you, view trial NCT01349322 on ClincialTrials.gov.