Clinical trial NCT06961955: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Invasive Carcinoma of Breast
Ductal Breast Carcinoma in Situ
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.
timeFrame: 3 years
Secondary outcomes:
measure: Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by type
timeFrame: 5 years
measure: 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)
timeFrame: 5 years
measure: Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness
timeFrame: 5 years
measure: Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration
timeFrame: 5 years
measure: Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by relationship to study treatment.
timeFrame: 5 years
measure: Evaluate non-inferiority of local and local regional recurrence rate in the treatment arms.
timeFrame: 8 years
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute
name: Matthew R. Poppe, MD
role: PRINCIPAL_INVESTIGATOR
References: