Breast CarcinomaNCT03612648
Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma
A study testing Three Fraction Accelerated Partial Breast Irradiation and Partial mastectomy in people with Breast Carcinoma and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Breast Cancer
- What is being tested?
- Three Fraction Accelerated Partial Breast Irradiation and Partial mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.
- Negative histologic margins of partial mastectomy or re-excision specimen. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.
- Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm).
- Neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed prior to TRI-APBI, but adjuvant hormone therapy may have been started after surgery. Planned chemotherapy or biologic therapy must not start for at least 4 weeks after the completion of TRI-APBI.
- Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation.
- Postmenopausal status.
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- Age ≥ 50 years at diagnosis.
- Able to understand and willing to sign IRB-approved written informed consent document.
- English speaker.
- All radiation therapy must be planned for delivery at BJH. External beam patients will be treated at BJH on a Viewray Unit, the Varian Edge unit, or the Varian Halcyon unit. Brachytherapy cases will be treated in the BJH brachytherapy center. Pre and post treatment care is allowed at any Siteman center.
Who cannot join
- Presence of distant metastases.
- Nonepithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
- Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.
- Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
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- Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years.
- History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Paget's disease of the nipple.
- Skin involvement, regardless of tumor size.
- Unsatisfactory breast for TRI-APBI as determined by the treating physician. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with TRI-APBI is technically problematic.
- Partial mastectomy so extensive that the cosmetic result is fair or poor prior to TRI-APBI as determined by the treating physician.
- Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.
- Time between final definitive breast procedures to TRI-APBI simulation is greater than 8 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma
The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take place at many radiation oncology centers with minimal specialized equipment beyond that commonly available. The investigators first step is this proposed single institution phase I/II study designed primarily to evaluate the tolerance of this approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).
- Conditions
- Breast Carcinoma, Breast Cancer
- Being tested
- Three Fraction Accelerated Partial Breast Irradiation, Partial mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three Fraction Accelerated Partial Breast IrradiationRadiation
Also called TRI-APBI
- TRI-APBI simulation must take place no more than 8 weeks from final definitive breast surgery
- Machines that could be used include: SAVI applicator, The ViewRay System for Radiation Therapy, The ViewRay (MRIdian) Linac System, Halcyon, True Beam, True Beam STx, Edge Radiotherapy Delivery System
Partial mastectomyProcedure or surgery
-Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| TRI-APBI | Experimental | * Brachytherapy TRI-APBI the PTV is prescribed 7.5 Gy x three fractions given over two to three days OR
* External beam TRI-APBI the PTV is prescribed 8.5 Gy x three fractions given over two to three days Receives: Radiation: Three Fraction Accelerated Partial Breast Irradiation; Procedure: Partial mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of Tri-APBI as measured by the rate of acute treatment-related grade 3 or higher toxicity or any other grade 4 or 5 toxicity attributed to treatment
- Adverse events will be graded using CTCAE Version 5.0
- Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis, and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis, coronary artery disease, and pericarditis
Measured: Through 8 weeks
Tolerance of Tri-APBI as measured by the rate of late treatment-related grade 3 or higher toxicity or any other grade 4 or 5 toxicity attributed to treatment
- Adverse events will be graded using CTCAE Version 5.0
- Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis, and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis, coronary artery disease, and pericarditis
Measured: Through 5 years after treatment
Ipsilateral breast tumor recurrence rate
-Recurrence of breast cancer in the treated breast is an ipsilateral breast tumor recurrence (IBTR)
Measured: 5 years after treatment
Secondary outcomes (10)
Proportion of participants who are free of breast cancer recurrence in the regional lymph nodes
-Defined as ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups
Measured: 5 years after treatment
Proportion of participants who are free of breast cancer distant metastases
Measured: 5 years after treatment
Change in Quality of life as measured by the EORTC QLQ-30 questionnaire
The QLQ-C30 includes 6 general questions and 24 questions in 9 subscales measuring physical, role, emotional, cognitive and social function, as well as global health status, nausea/ vomiting, pain and fatigue
- Each of the subscales will be tabulated and presented graphically over the assessment times. Mixed repeated measures models will be generated to describe the nature of change in quality of life over time
- Responses vary from 1=Not at All to 4 = Very Much
Measured: Before treatment, 8 weeks, 6 months, 12 months, 24 months, year 4, and year 5
Change in Quality of life as measured by the EORTC QLQ-BR23 questionnaire
- The QLQ-B23 provides 23 questions in 8 breast cancer specific subscales, 4 measuring symptoms and 4 measuring function
- Each of the subscales will be tabulated and presented graphically over the assessment times. Mixed repeated measures models will be generated to describe the nature of change in quality of life over time
- Responses vary from 1=Not at All to 4 = Very Much
Measured: Before treatment, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Change in Cosmesis as measured by the Breast Retraction Assessment
- Cosmesis will be graded by the patient and the radiation oncologist (or nurse practitioner) before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
- The Breast Retraction Assessment consists of measuring certain parts of a participant's chest and then using a formula to come up with the measurements
Measured: Before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
Change in Cosmesis as measured by the Percent Breast Retraction Assessment
- Cosmesis will be graded by the patient and the radiation oncologist (or nurse practitioner) before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
- The Percent Breast Retraction Assessment consists of measuring certain parts of a participant's chest and then using a formula to come up with the measurements
Measured: Before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
Change in Cosmesis as measured by the Aronson modified Harris scale
- Cosmesis will be graded by the patient \& radiation oncologist (or nurse practitioner) before treatment, 6-10 weeks after TRI-APBI, 4-8 month follow-up, 10-14 month follow-up, \& yearly intervals for a total of 5 years following TRI-APBI
- The Aaronson modification of the Harris scale will be used to evaluate cosmesis \& the scale consists of:
- Excellent-when compared to the untreated breast, there is minimal or no difference in the size, shape or texture of the treated breast - may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance
- Good-mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape
- Fair-obvious difference in the size \& shape of the treated breast. This change involves 1/4 or less of the breast
- Poor-marked change in the appearance of the treated breast involving more than 1/4 of the breast tissue
Measured: Before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
Presence of complications using CTCAE Version 5.0 criteria
Measured: Through 5 years after treatment
Proportion of participants undergoing mastectomy on the treated side
Measured: 5 years after treatment
Frequency of any CTCAE Version 5.0 grade 3-4 toxicities
Measured: Through 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start30 Aug 2018
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Zoberi, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612648
- Sponsor's protocol ID
- 201808046
- Status last verified
- Apr 2026
- First submitted
- 26 Jul 2018
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma
- ClinicalTrials.gov ID
- NCT03612648
- Acronym / sponsor ID
- 201808046
- Conditions
- Breast Carcinoma, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 2 Aug 2018 (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 investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take place at many radiation oncology centers with minimal specialized equipment beyond that commonly available. The investigators first step is this proposed single institution phase I/II study designed primarily to evaluate the tolerance of this approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRI-APBI | Experimental | Radiation: Three Fraction Accelerated Partial Breast Irradiation, Procedure: Partial mastectomy* Brachytherapy TRI-APBI the PTV is prescribed 7.5 Gy x three fractions given over two to three days OR * External beam TRI-APBI the PTV is prescribed 8.5 Gy x three fractions given over two to three days |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.
- Negative histologic margins of partial mastectomy or re-excision specimen. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.
- Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm).
- Neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed prior to TRI-APBI, but adjuvant hormone therapy may have been started after surgery. Planned chemotherapy or biologic therapy must not start for at least 4 weeks after the completion of TRI-APBI.
- Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation.
Key exclusion criteria (14 listed)
- Presence of distant metastases.
- Nonepithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
- Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.
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 |
|---|---|---|
| Three Fraction Accelerated Partial Breast IrradiationAlso: TRI-APBI* TRI-APBI simulation must take place no more than 8 weeks from final definitive breast surgery * Machines that could be used include: SAVI applicator, The ViewRay System for Radiation Therapy, The ViewRay (MRIdian) Linac System, Halcyon, True Beam, True Beam STx, Edge Radiotherapy Delivery System | Radiation | TRI-APBI |
| Partial mastectomy-Standard of Care | Procedure or surgery | TRI-APBI |
Primary outcome
Tolerance of Tri-APBI as measured by the rate of acute treatment-related grade 3 or higher toxicity or any other grade 4 or 5 toxicity attributed to treatment
Time frame: Through 8 weeks
* Adverse events will be graded using CTCAE Version 5.0 * Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis, and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis, coronary artery disease, and pericarditis
Tolerance of Tri-APBI as measured by the rate of late treatment-related grade 3 or higher toxicity or any other grade 4 or 5 toxicity attributed to treatment
Time frame: Through 5 years after treatment
* Adverse events will be graded using CTCAE Version 5.0 * Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis, and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis, coronary artery disease, and pericarditis
Ipsilateral breast tumor recurrence rate
Time frame: 5 years after treatment
-Recurrence of breast cancer in the treated breast is an ipsilateral breast tumor recurrence (IBTR)
10 secondary outcomes
Proportion of participants who are free of breast cancer recurrence in the regional lymph nodes
Time frame: 5 years after treatment
Proportion of participants who are free of breast cancer distant metastases
Time frame: 5 years after treatment
Change in Quality of life as measured by the EORTC QLQ-30 questionnaire
Time frame: Before treatment, 8 weeks, 6 months, 12 months, 24 months, year 4, and year 5
Change in Quality of life as measured by the EORTC QLQ-BR23 questionnaire
Time frame: Before treatment, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Change in Cosmesis as measured by the Breast Retraction Assessment
Time frame: Before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
Change in Cosmesis as measured by the Percent Breast Retraction Assessment
Time frame: Before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
Change in Cosmesis as measured by the Aronson modified Harris scale
Time frame: Before treatment, 6-10 weeks after TRI-APBI, at 4-8 month follow-up, at 10-14 month follow-up, and at yearly intervals thereafter for a total of 5 years following TRI-APBI
Presence of complications using CTCAE Version 5.0 criteria
Time frame: Through 5 years after treatment
Proportion of participants undergoing mastectomy on the treated side
Time frame: 5 years after treatment
Frequency of any CTCAE Version 5.0 grade 3-4 toxicities
Time frame: Through 5 years after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Imran Zoberi, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three Fraction Accelerated Partial Breast Irradiation and Partial mastectomy in people with Breast Carcinoma and Breast Cancer, run by Washington University School of Medicine 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 5 May 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of Tri-APBI as measured by the rate of acute treatment-related grade 3 or higher toxicity or any other grade 4 or 5 toxicity attributed to treatment (time frame: Through 8 weeks). The study lists 3 primary outcomes in all. 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 5 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.