Breast CancerNCT02400658
Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer
A study testing IORT with CT-Guided HDR Brachytherapy in people with Breast Cancer, run by Shayna Showalter, MD at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IORT with CT-Guided HDR Brachytherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2015to Sep 2027
- Phase
- Interventional
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
- Tumor size must be less than or equal to 3 cm.
- Patient is 45 years of age or older.
Who cannot join
- Male patients.
- Pregnant patients.
- Breast cancer that involves the skin or chest wall.
- History of ipsilateral breast cancer.
- Multicentric breast cancer in the ipsilateral breast.
- Known BRCA gene mutation.
Show all 9Show fewer
- Patient with nodal disease.
- Patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size.
- Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22908
Hackensack Meridian Health - John Theurer Cancer Center
Hackensack, New Jersey, 07601
Thomas Jefferson University
Philadelphia, Pennsylvania, 19147
About this study
Official title: A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.
Read the detailed description
This is a prospective single-arm phase II study designed to study the efficacy of high dose rate (HDR) brachytherapy with CT-imaging, single-fraction intraoperative radiation therapy (IORT). The study will accrue patients with early-stage breast cancer who will be treated with breast-conserving surgery (BCS). The main clinical eligibility criterion is based on suitability for accelerated partial breast irradiation. Patients may be eligible prior to receiving BCS or within 30 days of receiving BCS. Eligible patients that will undergo BCS will receive surgery according to the standard clinical practice in the Brachytherapy Suite in the Emily Couric Clinical Cancer Center. Patients that have already undergone BCS must meet all other eligibility criteria and are able to be treated with IORT within 30 days of their breast surgery. Eligible subjects will undergo a lumpectomy or re-excision lumpectomy according the standard clinical practice. Immediately following lumpectomy, the breast HDR brachytherapy applicator will be placed and CT imaging will be performed for treatment planning. After HDR brachytherapy is delivered, the applicator will be removed, and the breast surgeon will complete the skin closure. Although the ultimate goal of the study is to determine 5-year ipsilateral breast tumor recurrence (IBTR), all efforts will be made to follow the patients until death.
- Conditions
- Breast Cancer
- Being tested
- IORT with CT-Guided HDR Brachytherapy
- Keywords
- breast cancer, early-stage, IORT, brachytherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IORT with CT-Guided HDR BrachytherapyDevice
Also called Surgery, Breast Lumpectomy
This therapy targets the cancer cells directly, reducing the volume of breast tissue exposed to the radiation and the risks involved with the radiation. CT imaging will be used via a multichannel/multi-dwell balloon catheter to better sculpt the cancer away from the heart, skin, and ribs.
| Study group | Role | What they receive |
|---|---|---|
| IORT with CT-Guided HDR Brachytherapy | Experimental | Patients will receive IORT with CT-guided HDR brachytherapy at the time of breast surgery. Receives: Device: IORT with CT-Guided HDR Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Local Breast Tumor Recurrence
Measured: Up to 60 Months After Treatment
Secondary outcomes (8)
Rate of Ipsilateral Breast Tumor (Not Local) Recurrence
Measured: Up to 60 Months After Treatment
Rate of Distant Recurrence of Breast Cancer
Measured: Up to 60 Months After Treatment
Cancer Specific-Survival and Overall Survival Response Rate
Measured: Minimum of 60 Months After Treatment
Changes in Reported Patient and Physician Cosmetic Descriptions
Measured: Up to 60 Months After Treatment
Comparison of Pre-and Post Pathology Stratum
Measured: Up to 60 Months After Treatment
Changes in Patient-Reported Quality of Life
Measured: Up to 60 Months After Treatment
Number of Participants with Adverse Events
Safety and toxicity of treatment will be determined with the Common Toxicity Criteria for Adverse Effects.
Measured: 24 Months After Treatment
Changes of Radiographic Breast Appearance
Measured: Up to 60 Months After Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shayna Showalter, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shayna Showalter, MD, University of Virginia
- Investigators
- Shayna Showalter, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400658
- Sponsor's protocol ID
- 18004
- Other IDs
- IORT2
- Status last verified
- Jan 2023
- First submitted
- 12 Mar 2015
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reyes-Matos M, Turkheimer LM, Campbell CA, Showalter SL. Beauty Is in the Eye of the Beholder: Cosmetic Outcomes After Precision Breast Intraoperative Radiation Therapy. J Surg Res. 2025 Nov;315:210-217. doi: 10.1016/j.jss.2025.09.029. Epub 2025 Oct 6.
PubMed 41056841Turkheimer LM, Petroni GR, Berger AC, Schroen AT, Brenin DR, Lazar M, Libby B, Janowski EM, Showalter TN, Showalter SL. Novel Form of Breast Intraoperative Radiation Therapy with CT-Guided High-Dose-Rate Brachytherapy: Interim Results of a Prospective Phase-II Clinical Trial. J Am Coll Surg. 2024 Jan 1;238(1):10-20. doi: 10.1097/XCS.0000000000000869. Epub 2023 Oct 23.
PubMed 37870228Meneveau MO, Petroni GR, Varhegyi NE, Hulse JC, Schroen AT, Brenin DR, Janowski EM, Berger AC, Lazar MA, Simone NL, Showalter TN, Showalter SL. Toxicity and cosmetic outcomes after treatment with a novel form of breast IORT. Brachytherapy. 2020 Sep-Oct;19(5):679-684. doi: 10.1016/j.brachy.2020.05.002. Epub 2020 Jun 20.
PubMed 32571746
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02400658
- Acronym / sponsor ID
- 18004
- Conditions
- Breast Cancer
- Keywords
- breast cancer, early-stage, IORT, brachytherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Shayna Showalter, MDUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Mar 2015 (estimated)
- 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 purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.
Detailed description
This is a prospective single-arm phase II study designed to study the efficacy of high dose rate (HDR) brachytherapy with CT-imaging, single-fraction intraoperative radiation therapy (IORT). The study will accrue patients with early-stage breast cancer who will be treated with breast-conserving surgery (BCS). The main clinical eligibility criterion is based on suitability for accelerated partial breast irradiation. Patients may be eligible prior to receiving BCS or within 30 days of receiving BCS. Eligible patients that will undergo BCS will receive surgery according to the standard clinical practice in the Brachytherapy Suite in the Emily Couric Clinical Cancer Center. Patients that have already undergone BCS must meet all other eligibility criteria and are able to be treated with IORT within 30 days of their breast surgery. Eligible subjects will undergo a lumpectomy or re-excision lumpectomy according the standard clinical practice. Immediately following lumpectomy, the breast HDR brachytherapy applicator will be placed and CT imaging will be performed for treatment planning. After HDR brachytherapy is delivered, the applicator will be removed, and the breast surgeon will complete the skin closure. Although the ultimate goal of the study is to determine 5-year ipsilateral breast tumor recurrence (IBTR), all efforts will be made to follow the patients until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IORT with CT-Guided HDR Brachytherapy | Experimental | Device: IORT with CT-Guided HDR BrachytherapyPatients will receive IORT with CT-guided HDR brachytherapy at the time of breast surgery. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
- Tumor size must be less than or equal to 3 cm.
- Patient is 45 years of age or older.
Key exclusion criteria (9 listed)
- Male patients.
- Pregnant patients.
- Breast cancer that involves the skin or chest wall.
- History of ipsilateral breast cancer.
- Multicentric breast cancer in the ipsilateral breast.
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 |
|---|---|---|
| IORT with CT-Guided HDR BrachytherapyAlso: Surgery, Breast LumpectomyThis therapy targets the cancer cells directly, reducing the volume of breast tissue exposed to the radiation and the risks involved with the radiation. CT imaging will be used via a multichannel/multi-dwell balloon catheter to better sculpt the cancer away from the heart, skin, and ribs. | Device | IORT with CT-Guided HDR Brachytherapy |
Primary outcome
Rate of Local Breast Tumor Recurrence
Time frame: Up to 60 Months After Treatment
8 secondary outcomes
Rate of Ipsilateral Breast Tumor (Not Local) Recurrence
Time frame: Up to 60 Months After Treatment
Rate of Distant Recurrence of Breast Cancer
Time frame: Up to 60 Months After Treatment
Cancer Specific-Survival and Overall Survival Response Rate
Time frame: Minimum of 60 Months After Treatment
Changes in Reported Patient and Physician Cosmetic Descriptions
Time frame: Up to 60 Months After Treatment
Comparison of Pre-and Post Pathology Stratum
Time frame: Up to 60 Months After Treatment
Changes in Patient-Reported Quality of Life
Time frame: Up to 60 Months After Treatment
Number of Participants with Adverse Events
Time frame: 24 Months After Treatment
Changes of Radiographic Breast Appearance
Time frame: Up to 60 Months After Treatment
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 25 Jan 2023.
- Derived from this study: PubMed 41056841Reyes-Matos M, Turkheimer LM, Campbell CA, Showalter SL. Beauty Is in the Eye of the Beholder: Cosmetic Outcomes After Precision Breast Intraoperative Radiation Therapy. J Surg Res. 2025 Nov;315:210-217. doi: 10.1016/j.jss.2025.09.029. Epub 2025 Oct 6.
- Derived from this study: PubMed 37870228Turkheimer LM, Petroni GR, Berger AC, Schroen AT, Brenin DR, Lazar M, Libby B, Janowski EM, Showalter TN, Showalter SL. Novel Form of Breast Intraoperative Radiation Therapy with CT-Guided High-Dose-Rate Brachytherapy: Interim Results of a Prospective Phase-II Clinical Trial. J Am Coll Surg. 2024 Jan 1;238(1):10-20. doi: 10.1097/XCS.0000000000000869. Epub 2023 Oct 23.
- Derived from this study: PubMed 32571746Meneveau MO, Petroni GR, Varhegyi NE, Hulse JC, Schroen AT, Brenin DR, Janowski EM, Berger AC, Lazar MA, Simone NL, Showalter TN, Showalter SL. Toxicity and cosmetic outcomes after treatment with a novel form of breast IORT. Brachytherapy. 2020 Sep-Oct;19(5):679-684. doi: 10.1016/j.brachy.2020.05.002. Epub 2020 Jun 20.
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. This study is not recruiting at the moment.
Shayna Showalter principal investigator
University of Virginia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IORT with CT-Guided HDR Brachytherapy in people with Breast Cancer, run by Shayna Showalter, MD at 3 sites 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
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?
Rate of Local Breast Tumor Recurrence (time frame: Up to 60 Months After Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400658, which also lists 3 linked publications.
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 25 Jan 2023.