RecruitingPhase 2NCT06961955

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

Sponsor

University of Utah

Enrollment

144 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Invasive Carcinoma of Breast

Summary

The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria25

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 Criteria18

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.