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

NCT06961955 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: HCI189208
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.

  To evaluate non-inferiority of 24-month Breast-Q satisfaction with breast score with 5 versus 9 fractions of radiation.

  3 years

Secondary Outcomes (8)

• Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by type

  5 years

• 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

• Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness

  5 years

• Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration

  5 years

• 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

Study Arms (2)

5 fractions of radiotherapy (Arm 1)

EXPERIMENTAL

Radiation: Radiation Therapy

9 fractions of radio therapy (Arm 2)

ACTIVE COMPARATOR

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

5 fractions of radiotherapy (Arm 1); 9 fractions of radio therapy (Arm 2)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female participant aged ≥ 18 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Matthew R. Poppe, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Kingsford

CONTACT

801-585-0115; rachel.kingsford@hci.utah.edu

David Samuel

CONTACT

801-587-4713; david.samuel@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study will have no masking as the treating investigator and patient will need to know their radiation schedule for accurate treatment planning.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2033
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)