No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 79
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
Virginia Commonwealth University · Other
Who this trial is looking for
This trial is looking for women with breast cancer who have recently been diagnosed. Participants will receive radiation treatment over about two days in three sessions.
Are You a Good Fit for This Trial?
You may be able to join if
I am female.
I have a new diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer.
I am between 45 and 79 years old.
I have had a lumpectomy with clean surgical margins.
My tumor size is Tis, T1, or T2 with T2 tumors ≤3 cm.
If my tumor is HER2-positive, I will get HER2 therapy.
I am able to understand and sign the consent form.
You may not be able to join if
I am pregnant or breastfeeding.
I have active collagen-vascular disease.
I have a history of Paget's disease of the breast.
I have been diagnosed with breast cancer before this current diagnosis.
I have had previous radiation therapy for any condition.
I have multicentric carcinoma.
I have bilateral breast cancer diagnosed at the same time.
I have conditions that could affect my ability to follow the study's requirements.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Female
* New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
* Age 45-79 at diagnosis
* Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist.
* T stage …
Inclusion Criteria:
* Female
* New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
* Age 45-79 at diagnosis
* Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist.
* T stage of Tis, T1, or T2.
* T2 tumors must be ≤3 cm in maximum diameter
* If the tumor is human epidermal growth factor receptor 2 (HER2)-positive, the patient must receive HER2-directed therapy.
* For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node\[s\] must be pathologically negative.
* Note: N0(i+) is not an exclusion criterion.
* Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:
* ≥70 years of age
* estrogen receptor, Her2 = human epidermal growth factor receptor 2, PR = progesterone receptor negative (ER+PR+HER2-)
* G1-2
* Tumor ≤2 cm in size
* Agrees to comply with aromatase inhibitor recommendation
* Ability to understand and the willingness to sign a written informed consent document in English
Exclusion Criteria:
* Pregnant or breastfeeding
* Active collagen-vascular disease
* Paget's disease of the breast
* History of DCIS or invasive breast cancer prior to the current diagnosis
* Prior breast or thoracic radiation therapy (RT) for any condition
* Multicentric carcinoma (DCIS or invasive)
* Synchronous bilateral invasive or non-invasive breast cancer
* Surgical margins that cannot be microscopically assessed or that are positive
* Excision cavity that cannot be clearly delineated per the treating investigator
* Any of the dosimetric treatment criteria defined in Section 6.1 have not been met. Patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as - defined in this protocol and will come off the study. Any subsequent adjuvant radiation will be delivered at the discretion of the treating physician
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
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