Breast Cancer, Ductal Breast Carcinoma in Situ, Invasive Carcinoma of Breast
Conditions
Brief summary
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
Interventions
RADIATIONRadiation Therapy
Undergo hypofractionated radiation therapy
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Study will have no masking as the treating investigator and patient will need to know their radiation schedule for accurate treatment planning.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes. | 3 years | To evaluate non-inferiority of 24-month Breast-Q satisfaction with breast score with 5 versus 9 fractions of radiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by severity (as defined by the NIH CTCAE, version 5.0) | 5 years | To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity. |
| Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness | 5 years | To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity. |
| Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration | 5 years | To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity. |
| Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by type | 5 years | To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity. |
| Evaluate non-inferiority of local and local regional recurrence rate in the treatment arms. | 8 years | To evaluate non-inferiority of the local and local regional recurrence rate between the two arms. |
| Evaluate non-inferiority of a change in cosmetic scores in the treatment arms with pre-radiation scores to post 24-month scores using the UK photographic assessment and EORTC scales. | 5 years | To evaluate non-inferiority of the breast photographic cosmetic outcomes of the UK and EORTC scales |
| 60-month mean breast overall satisfaction Breast-Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes. | 5 years | To evaluate non-inferiority of the mean Breast-Q scores with 5 fractions of radiation at 60 months. |
| Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by relationship to study treatment. | 5 years | To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity. |
Countries
United States
Contacts
Primary ContactRachel Kingsford
Backup ContactDavid Samuel
Outcome results
None listed