Breast CancerNCT03536897
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
An observational study of Breast Cancer, run by Mount Carmel Health System at 1 site in United States.
Trial summary
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IORT
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to 27 Feb 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: Women aged 65 and above with early stage breast cancer, ER+, low to intermediate grade invasive ductal carcinoma of the breast amenable to breast conserving surgery and radiation therapy.
Who may be able to join
- Female
- ECOG performance status 0-1
- Age 65 years or older
- cT1 or cT2 (≤3.0 cm)
- Invasive ductal carcinoma histology
- Estrogen receptor positive (ER+)
Show all 10Show fewer
- Grade 1 or Grade 2
- Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
- Suitable for breast conserving surgery and radiation therapy
- Patient must be able to provide study-specific informed consent
Who cannot join
- Multi-centric cancer not amenable to single lumpectomy
- Prior ipsilateral whole breast radiation
- Known BRCA 1 or BRCA 2 mutation
- Status post neoadjuvant hormonal or chemotherapy
- Invasive lobular histology
- Pure ductal carcinoma in situ (DCIS)
- Grade 3
- Diffuse suspicious microcalcifications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
- Conditions
- Breast Cancer
- Being tested
- IORT
- Keywords
- breast cancer, invasive ductal carcinoma, intraoperative radiation therapy, iort
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IORTRadiation
Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy
| Study group | Role | What they receive |
|---|---|---|
| IORT | All patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years. Receives: Radiation: IORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Breast Tumor Recurrence (IBTR)
Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
Measured: 5 years
Secondary outcomes (4)
Late Toxicity
Degree of late radiation toxicity will be scored based upon RTOG/EORTC (Radiation Therapy Oncology Group/Eastern Oncology Radiation Therapy Consortium) late radiation morbidity scoring schema for subcutaneous tissue as well as cosmetic result.
The RTOG/EORTC late radiation morbidity scoring schema on subcutaneous tissue is as follows:
- GRADE 1: Slight induration (fibrosis) and loss of subcutaneous fat
- GRADE 2: Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction
- GRADE 3: Severe induration and loss of subcutaneous tissue; field contracture > 10% linear measurement
- GRADE 4: Necrosis
Measured: 5 years
Acute Toxicity
Acute radiation toxicity will be scored at the first follow-up visit after IORT (4-6 weeks after treatment).
Radiation dermatitis will be scored based upon CTCAE (Common Terminology Criteria for Adverse Events) v4.03 scale as follows:
- GRADE 1: Faint erythema or dry desquamation
- GRADE 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema
- GRADE 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion
- GRADE 4: Life threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated
Other acute toxicity will also be scored per the CTCAE v4.03 scale and will be rated on the relation to radiation therapy (definitely related, probably related, possibly related, unlikely related, unrelated)
Measured: 3 months
Disease Free Survival
Disease Free Survival
Measured: 5 yeras
Overall Survival
Overall Survival
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 posted25 May 2018
- Study start27 Feb 2018
- Primary completion27 Feb 2028 (estimated)
- Study completion27 Feb 2028 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mount Carmel Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malolan Rajagopalan, MD, Principal investigator, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536897
- Sponsor's protocol ID
- 180212-1
- Status last verified
- Oct 2026
- First submitted
- 7 May 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
- ClinicalTrials.gov ID
- NCT03536897
- Acronym / sponsor ID
- 180212-1
- Conditions
- Breast Cancer
- Keywords
- breast cancer, invasive ductal carcinoma, intraoperative radiation therapy, iort
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Mount Carmel Health SystemUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 27 Feb 2028 (estimated)
- Study completion
- 27 Feb 2028 (estimated)
- First posted
- 25 May 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.
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IORT | – | Radiation: IORTAll patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Women aged 65 and above with early stage breast cancer, ER+, low to intermediate grade invasive ductal carcinoma of the breast amenable to breast conserving surgery and radiation therapy.
Key inclusion criteria (10 listed)
- Female
- ECOG performance status 0-1
- Age 65 years or older
- cT1 or cT2 (≤3.0 cm)
- Invasive ductal carcinoma histology
Key exclusion criteria (8 listed)
- Multi-centric cancer not amenable to single lumpectomy
- Prior ipsilateral whole breast radiation
- Known BRCA 1 or BRCA 2 mutation
- Status post neoadjuvant hormonal or chemotherapy
- Invasive lobular histology
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 |
|---|---|---|
| IORTIntraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy | Radiation | IORT |
Primary outcome
In-Breast Tumor Recurrence (IBTR)
Time frame: 5 years
Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
4 secondary outcomes
Late Toxicity
Time frame: 5 years
Acute Toxicity
Time frame: 3 months
Disease Free Survival
Time frame: 5 yeras
Overall Survival
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 13 Oct 2026.
- 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.
Malolan Rajagopalan, MD principal investigator
Mount Carmel Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mount Carmel Health System 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 8 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 13 Oct 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?
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?
In-Breast Tumor Recurrence (IBTR) (time frame: 5 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 13 Oct 2026.