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

Official title

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

Overview

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

Interventions

• Radiation Radiation Therapy
  Undergo hypofractionated radiation therapy

Primary outcome measures

• 24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes. [Time frame: 3 years]

Secondary outcome measures (8)

• Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by type [Time frame: 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) [Time frame: 5 years]
• Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness [Time frame: 5 years]
• Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration [Time frame: 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. [Time frame: 5 years]
• Evaluate non-inferiority of local and local regional recurrence rate in the treatment arms. [Time frame: 8 years]
• 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. [Time frame: 5 years]
• 60-month mean breast overall satisfaction Breast-Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes. [Time frame: 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Huntsman Cancer Institute/University of Utah — Salt Lake City

Identifiers

NCT: NCT06961955 · HCI189208

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗