MRI-Based Preoperative Accelerated Partial Breast Irradiation
United States39 participantsStarted 2016-07-29
Plain-language summary
This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.
Who can participate
Age range
40 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:
* Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
* Female
* Age ≥40 years
* Estrogen receptor positive
* Patients with both her2 positive and her2 negative tumors are eligible
* Unifocal disease
* Invasive ductal carcinoma diagnosed by core needle biopsy
* Clinically node negative both by physical exam and by ultrasound. All enlarged or abnormal appearing lymph nodes must be biopsied.
* Zubrod performance status 0-2
* Study entry must be within 120 days from initial diagnosis of breast cancer.
* Complete blood count (CBC) /differential obtained within 14 days prior to study entry, with adequate bone marrow function defined as follows: Absolute neutrophil count ≥ 1,800 cells/mm\^3; Platelets ≥ 75,000 cells/mm\^3; Hemoglobin ≥8.0g/dl.
* Not pregnant or lactating; willing to use acceptable forms of contraception during radiation therapy.
* Prior breast augmentation, including breast implants, is allowed.
* Patients with a prior history of contralateral breast cancer will be considered eligible if they completed all treatment (including anti-endocrine therapy) more than five years prior to registration.
* Patients must not have a prior treatment of malignancy diagnosed or treated within the past five years, with the exception of non-melanomatous skin cancer, carcinoma in situ of the cervix and contralateral breast cancer.
* Interested patients must meet with a medical oncologist prior to study entry to determine if Oncotype …
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.