Breast CancerPhase 2FAST NOVEMBERNCT06961955
5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
A Phase 2 study testing Radiation Therapy in people with Breast Cancer and Invasive Carcinoma of Breast, run by University of Utah at 1 site in United States.
Trial summary
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Invasive Carcinoma of Breast, Ductal Breast Carcinoma in Situ
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to May 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Rachel Kingford, 801-585-0115, rachel.kingsford@hci.utah.edu
David Samuel, 801-587-4713, david.samuel@hci.utah.edu
About this study
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
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
- Being tested
- Radiation Therapy
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Undergo hypofractionated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 5 fractions of radiotherapy (Arm 1) | Experimental | Not described Receives: Radiation: Radiation Therapy |
| 9 fractions of radio therapy (Arm 2) | Active comparator | Not described Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Measured: 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)
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Measured: 5 years
Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Measured: 5 years
Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Measured: 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.
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Measured: 5 years
Evaluate non-inferiority of local and local regional recurrence rate in the treatment arms.
To evaluate non-inferiority of the local and local regional recurrence rate between the two arms.
Measured: 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.
To evaluate non-inferiority of the breast photographic cosmetic outcomes of the UK and EORTC scales
Measured: 5 years
60-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 the mean Breast-Q scores with 5 fractions of radiation at 60 months.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start21 May 2025
- Primary completionMay 2030 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew R. Poppe, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961955
- Sponsor's protocol ID
- HCI189208
- Acronym
- FAST NOVEMBER
- Status last verified
- Dec 2025
- First submitted
- 29 Apr 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06961955
- Acronym / sponsor ID
- FAST NOVEMBER / HCI189208
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 fractions of radiotherapy (Arm 1) | Experimental | Radiation: Radiation Therapy |
| 9 fractions of radio therapy (Arm 2) | Active comparator | Radiation: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Female participant aged ≥ 18 years.
- 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
Key exclusion criteria (18 listed)
- Bilateral breast cancer.
- Prior radiation therapy to the chest.
- Prior chemotherapy.
- Recurrent disease.
- Known metastases or node positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyUndergo hypofractionated radiation therapy | Radiation | 5 fractions of radiotherapy (Arm 1), 9 fractions of radio therapy (Arm 2) |
Primary outcome
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
To evaluate non-inferiority of 24-month Breast-Q satisfaction with breast score with 5 versus 9 fractions of radiation.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew R. Poppe, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Therapy in people with Breast Cancer and Invasive Carcinoma of Breast, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Kingsford (801-585-0115, rachel.kingsford@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.