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

Phase 2

Not yet recruiting

• Conditions: Breast Cancer; Invasive Carcinoma of Breast; Ductal Breast Carcinoma in Situ

• Registration Number: NCT06961955
• Lead Sponsor: University of Utah

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Status Verified: 2025-05
• Study First Posted: 2025-05-08
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2025-06
• Primary Completion: 2030-06
• Study Completion: 2033-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

• Female participant aged ≥ 18 years.

  • Participants > 50 years must have at least one of the following risk factors:

    • Grade 3 invasive histology
    • Estrogen receptor positivity less than 5%
    • Lymphovascular invasion
    • Margins <2mm on surgical pathology
    • Extensive intraductal component

  • Participants ≤ age 50 need no additional risk factors.

• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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

Trial Locations

Locations (1)

Huntsman Cancer Institute/University of Utah; 🇺🇸 Salt Lake City, Utah, United States