A Phase 2 interventional study of Breast Radiotherapy in Breast Cancer, Early-stage Breast Cancer and Ductal Carcinoma in Situ, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States — 31 open to participants now, 51 under way, 6 of them phase 3. Carcinoma, Intraductal, Noninfiltrating · United States.
Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, this one is the 62nd largest by planned enrollment of the 171 interventional ones that give a count, is one of 7 that started in 2025, is one of 60 in phase 2, reaches primary completion later than 36 of the 50 other live ones, and was the 203rd registered.
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
Browse Carcinoma, Intraductal, Noninfiltrating studies →31 of the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States are open now. Recruiting first, the newest first:
Providence Health & Services · Sites in United States
Ages 18+
HeroSupport SA · Sites in United States
Ages 40+ · Women only
University of Florida · Sites in United States
Ages 18+
Barbara Ann Karmanos Cancer Institute · Sites in United States
Ages 18+ · Women only
National Cancer Institute (NCI) · Sites in United States
Ages 45–74 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 42 Carcinoma, Intraductal, Noninfiltrating studies recruiting now, 33 (79%) set no upper age limit and 5 (12%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 50 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
210 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 68 · Phase 3 15 · Phase 4 1
First in 1991; this study’s year is marked. 7 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is above the median of 66 across 208 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Median enrollment 51 across the 171 interventional studies, 109 across the 38 observational. Of the 140 that completed or were terminated, 59 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 210 have an industry lead sponsor. The 10 most frequent:
UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
UNC Lineberger Comprehensive Cancer Center has 2 studies filed under Carcinoma, Intraductal, Noninfiltrating — fewer than ten, so there is no comparison to draw.
15 of the studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04722692Phase 3Uppsala UniversityDelayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ | 2026-12-30 |
| NCT03546972M.D. Anderson Cancer CenterDiabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants | 2026-11-30 |
| NCT03909282Stanford UniversitySurgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma | 2026-12 |
| NCT03448926PreludeDxThe PREDICT Registry: | 2026-12 |
| NCT05340673City of Hope Medical CenterComparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer | 2026-12-15 |
Add all 15 to your calendar (.ics) → With an account.
Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy.
The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.
Multiple recent studies demonstrate the noninferiority of a simultaneous integrated boost (SIB) approach. This study will include women aged 50 years and older who are recommended to receive whole breast irradiation with a standard dose boost and without regional nodal irradiation.
Radiation therapy will consist of 5 fractions delivered every other day (excluding weekends), with a total dose of 26 Gy to the whole breast and a simultaneous integrated boost to a total dose of 30 Gy to the lumpectomy cavity.
The primary outcome of this study is to investigate the rate of moderate to marked adverse effects in the breast and chest wall of patients receiving five-fraction whole-breast radiation therapy with a concurrent boost. Radiation-specific toxicity outcomes will be assessed by clinicians and patients at 12 months, along with evaluations of quality of life and oncologic control at 24 months following treatment.
It is hypothesized that 5-fraction whole breast irradiation with a simultaneous integrated boost will result in clinically acceptable rates of moderate to marked toxicity relative to historical controls, while providing good quality of life and high rates of disease control.
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
This study's planned enrollment of 90 is above the median of 66 across 208 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
Compared within Carcinoma, Intraductal, Noninfiltrating, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Five-fraction whole breast irradiation (WBI) with simultaneous integrated tumor bed boost (SIB).
Radiation: Breast Radiotherapy
The tumor bed boost when given at the same time (called a simultaneous integrated boost, SIB) with whole breast irradiation (WBI).
Rate of any moderate-marked adverse effects
The rate of moderate to marked adverse effects in the breast or chest wall at 1 year will be measured using a questionnaire called the Clinician Assessment of Radiation-Specific Toxicity by clinican. This will be compared against historical controls. The questionnaire includes 10 items: 4 Likert-type questions and 6 yes/no questions. Items are rated from 0 to 4, with higher scores indicating more adverse effects. A "yes" response indicates the occurrence of an adverse event.
Time frame: 1 year
In-breast tumor recurrence
In-breast tumor recurrence at 2 years is defined according to the standard definition as the time from enrollment to any of the following events: invasive ipsilateral recurrence and/or ipsilateral DCIS recurrence. Recurrence will be measured via medical record abstraction and clinical evaluation.
Time frame: 2 years
Quality of life at measured by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30)
Quality of life at 12 months will be measured as defined by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30). The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.
Time frame: 12 months
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Feb 2028, 36 months after the start.
Of 36 phase 2 interventional studies under Carcinoma, Intraductal, Noninfiltrating, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 117. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Intraductal, Noninfiltrating →
UNC Lineberger Comprehensive Cancer Center →