Outcomes and Cosmesis With Whole Breast Irradiation and Boost (NCT06295744) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Outcomes and Cosmesis With Whole Breast Irradiation and Boost
United States50 participantsStarted 2024-04-17
Plain-language summary
This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Ability to understand and the willingness to sign a written informed consent document
* Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or DCIS
* Breast conserving surgery with negative margins and negative nodes (surgical axillary staging not mandatory), stage N0 or Nx
* Treatment plan should include breast conserving surgery and adjuvant whole breast irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques
* Treatment plan includes breast tumor bed boost
* Willingness to comply with all study procedures and be available for the duration of the study
Exclusion Criteria:
* Mastectomy of ipsilateral breast
* Lack of histologic diagnosis
* Histologic involvement of the axillary or regional nodes or metastatic disease
* Accelerated partial breast irradiation treatment plan
* Previous history of non-breast malignancy diagnosed in the past 5 years except for basal or squamous cell cancer of the skin
* Previous history of chest radiation therapy
* Previous history of ipsilateral breast cancer
* Concurrent cytotoxic chemotherapy
* Active connective tissue disease including scleroderma
* Inability or unwillingness to return for required follow up visit
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
Harvard Breast Cosmesis Scale Score
Timeframe: up to 2 years post-treatment (treatment ends up to 5 weeks on study)