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 range50 Years
SexFEMALE
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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 ā„ 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.
Exclusionā¦
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