5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
FAST NOVEMBER: A Phase II Randomized Trial of a 5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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 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.
Study sites (1)
UT
- Huntsman Cancer Institute/University of Utah · Salt Lake City, UT 84112Rachel Kingford · Study contact · 801-585-0115 · rachel.kingsford@hci.utah.eduDavid Samuel · Study contact · 801-587-4713 · david.samuel@hci.utah.eduMatthew Poppe, MD · Principal investigatorMore trials in Salt Lake City