Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patie… (NCT02186470) | Clinical Trial Compass
CompletedNot Applicable
Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer
United States22 participantsStarted 2016-04-29
Plain-language summary
This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Who can participate
Age range
50 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:
* The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
* Patient must be ≥ 50 years
* Core biopsy demonstrating breast cancer and receptors that are ER or PR positive.
* Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines.
* The patient must have clinical node negative, stage I breast cancer.
* The surgical treatment must be intended to be a lumpectomy
* The biopsy site must have been demarcated by a clip(s)
* Gross disease must be unifocal on Mammo/ MRI imaging
* Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy
* Patient must be able to tolerate lying in the prone position with arms extended forward.
* Must be able to tolerate MRI scan with contrast
* At the time of enrollment, patients must have had bilateral mammograms within 6 months.
* Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI.
* Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
Exclusion…
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
The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
Timeframe: 4-6 weeks post-APBI
Trial details
NCT IDNCT02186470
SponsorOhio State University Comprehensive Cancer Center