5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer

NCT ID: NCT06961955

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-21
• Study Completion Date: 2033-05-31

Brief Summary

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

Conditions

Breast Cancer; Invasive Carcinoma of Breast; Ductal Breast Carcinoma in Situ

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5 fractions of radiotherapy (Arm 1)

Group Type: EXPERIMENTAL

Radiation Therapy

Intervention Type: RADIATION

Undergo hypofractionated radiation therapy

9 fractions of radio therapy (Arm 2)

Group Type: ACTIVE_COMPARATOR

Radiation Therapy

Intervention Type: RADIATION

Undergo hypofractionated radiation therapy

Interventions

Radiation Therapy

Undergo hypofractionated radiation therapy

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew R. Poppe, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute

Locations

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Kingsford

Role: CONTACT

rachel.kingsford@hci.utah.edu

801-585-0115

David Samuel

Role: CONTACT

david.samuel@hci.utah.edu

801-587-4713

Facility Contacts

Rachel Kingford

Role: primary

rachel.kingsford@hci.utah.edu

801-585-0115

David Samuel

Role: backup

david.samuel@hci.utah.edu

801-587-4713

Other Identifiers

HCI189208

Identifier Type: -

Identifier Source: org_study_id