Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer (NCT04871516) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
United States103 participantsStarted 2021-05-18
Plain-language summary
This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Breast cancer patients with biopsy proven invasive cancer
* Clinically and radiographically node negative
* No indication of metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Synchronous bilateral invasive cancer allowed
* Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery
* Willingness to participate in the clinical trial and adhere to the study protocol
* Individuals of all races, genders and ethnic groups are eligible for this trial
Exclusion Criteria:
* Need for neoadjuvant chemotherapy
* Inflammatory breast cancer (cT4)
* Multicentric tumor
* Prior ipsilateral breast or thoracic RT
* Contraindication for baseline magnetic resonance imaging (MRI)
* Contraindication for surgery
* Distant metastatic disease
* Other synchronous cancer (besides bilateral breast)
* Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease)
* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
Timeframe: For at least 36 months after WBI
Trial details
NCT IDNCT04871516
SponsorRutgers, The State University of New Jersey