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
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
144 (estimated)
Sponsor
University of Utah · Other
Who this trial is looking for
This trial is looking for women with early-stage breast cancer to compare two different lengths of radiation therapy. Participants will be treated with radiation for either 5 days or 9 days after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with breast cancer.
I had a lumpectomy within the last 84 days.
I have specific risk factors related to my cancer.
I am not currently pregnant or I am post-menopausal.
I can provide informed consent.
You may not be able to join if
I have bilateral breast cancer.
I have received prior radiation therapy to my chest.
I have had chemotherapy before.
I have recurrent cancer or known metastases.
I have significant health issues that would affect my participation.
I have had major chest surgery recently.
I have complications from recent surgery.
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 goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Female participant aged ≥ 18 years.
--Participants must have at least one of the following risk factors:
* Grade 3 invasive histology
* Estrogen receptor positivity less than 5%
* Lymphovascular invasion
* Invasive margins \<2mm on surgical pathology
* DCIS final …
Inclusion Criteria:
* Female participant aged ≥ 18 years.
--Participants must have at least one of the following risk factors:
* Grade 3 invasive histology
* Estrogen receptor positivity less than 5%
* Lymphovascular invasion
* Invasive margins \<2mm on surgical pathology
* DCIS final positive margin
* Extensive intraductal component
* Age ≤ 50 years
* Tumor size \> 2 cm
* Histologically confirmed invasive carcinoma or Ductal Carcinoma In Situ (DCIS) of the breast.
* Breast cancer stage (AJCC v8) T0-3, N0, M0. T0 N0 is allowed if whole breast radiation is recommended by the treating physician.
* Lumpectomy within 84 days of the start of radiation.
* ECOG Performance Status ≤ 2, or KPS ≥ 50
* Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia.
* Negative pregnancy test for participants of childbearing potential, evidence of permanent surgical sterilization, or post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* \< 50 years of age:
* Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
* Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
* ≥ 50 years of age:
* Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
* Had radiation-induced menopause with last menses \>1 year ago; or
* Had chemotherapy-induced menopause with last menses \>1 year ago
* Sexually active participants of childbearing potential must agree to use highly effective method of contraception (defined in Section 5.4.1) during the course of radiation and for 30 days after radiation.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
* Bilateral breast cancer.
* Prior radiation therapy to the chest.
* Prior chemotherapy.
* Recurrent disease.
* Known metastases or node positive.
* Major chest surgery which is expected to impact study participation 8 weeks prior to starting study drug.
* Prior breast malignancy in either breast.
* The diagnosis of any other malignancy which, in the opinion of the Investigator, is likely to negatively impact the subject's safety or ability to participate in the study.
* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
* Cardiovascular disorders:
* Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
* Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
* Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow, social/ psychological issues, etc.)
* Significant post lumpectomy complications requiring an unplanned re-operation for surgical complications or admission for IV antibiotics. Re-operation for margins evaluation or nodal evaluation is acceptable. Draining of a seroma is not considered a complication unless it has become infected.
* Breast neuroendocrine carcinoma or sarcoma histology.
* Radiation sensitizing disease or condition (e.g. connective tissue disease, li fremani, etc.).
* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
* Participants receiving concurrent radiation sensitizing medications or therapies.
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