Breast CancerNCT00185744
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
A study testing Intra-Operative Radiotherapy (IORT), Lumpectomy and Whole Breast Radiotherapy in people with Breast Cancer and Carcinoma, Ductal, run by Stanford University at 1 site in United States.
Trial summary
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, Carcinoma, Ductal
- What is being tested?
- Intra-Operative Radiotherapy (IORT), Lumpectomy and Whole Breast Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Mar 2029
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ
- Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
- Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
Who cannot join
- Men
- Prior malignancy, breast or other if metastatic or with anticipated survival of < 5 years
- Pregnant women
- Immunocompromised
- Poorly controlled insulin dependent diabetes
- Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
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- Breast cancer that involves skin or chest wall
- Multifocal or Multicentric breast cancer
- Invasive lobular carcinoma
- Diffuse microcalcifications on mammography
- Invasive carcinoma with extensive intraductal component (EIC)
- Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
- Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
- Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
- Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.
- Conditions
- Breast Cancer, Carcinoma, Ductal
- Being tested
- Intra-Operative Radiotherapy (IORT), Lumpectomy, Whole Breast Radiotherapy, Intracavitary Brachytherapy, Accelerated External Beam 3-D Conformal Radiotherapy
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Operative Radiotherapy (IORT)Radiation
single dose in the operating room after lumpectomy
LumpectomyProcedure or surgery
Whole Breast RadiotherapyRadiation
six and a half week treatment
Intracavitary BrachytherapyRadiation
Also called MammoSite
5 day treatment
Accelerated External Beam 3-D Conformal RadiotherapyRadiation
5 day treatment
Stereotactic APBIRadiation
4 day treatment
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Partial Breast Irradiation | Experimental | lumpectomy with accelerated partial breast irradiation Receives: Radiation: Intra-Operative Radiotherapy (IORT); Procedure: Lumpectomy; Radiation: Intracavitary Brachytherapy; Radiation: Accelerated External Beam 3-D Conformal Radiotherapy; Radiation: Stereotactic APBI |
| Standard Therapy | Active comparator | lumpectomy and whole breast irradiation Receives: Procedure: Lumpectomy; Radiation: Whole Breast Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-breast tumor recurrence (IBTR)
Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick M. Dirbas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185744
- Sponsor's protocol ID
- IRB-13807
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2005
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Horst KC, Fasola C, Ikeda D, Daniel B, Ognibene G, Goffinet DR, Dirbas FM. Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. Breast. 2016 Aug;28:178-83. doi: 10.1016/j.breast.2016.06.001. Epub 2016 Jun 17.
PubMed 27322859
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
- ClinicalTrials.gov ID
- NCT00185744
- Acronym / sponsor ID
- IRB-13807
- Conditions
- Breast Cancer, Carcinoma, Ductal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 16 Sep 2005 (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.
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated Partial Breast Irradiation | Experimental | Radiation: Intra-Operative Radiotherapy (IORT), Procedure: Lumpectomy, Radiation: Intracavitary Brachytherapy, Radiation: Accelerated External Beam 3-D Conformal Radiotherapy, Radiation: Stereotactic APBIlumpectomy with accelerated partial breast irradiation |
| Standard Therapy | Active comparator | Procedure: Lumpectomy, Radiation: Whole Breast Radiotherapylumpectomy and whole breast irradiation |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ
- Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
- Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
Key exclusion criteria (15 listed)
- Men
- Prior malignancy, breast or other if metastatic or with anticipated survival of < 5 years
- Pregnant women
- Immunocompromised
- Poorly controlled insulin dependent diabetes
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 |
|---|---|---|
| Intra-Operative Radiotherapy (IORT)single dose in the operating room after lumpectomy | Radiation | Accelerated Partial Breast Irradiation |
| Lumpectomy | Procedure or surgery | Accelerated Partial Breast Irradiation, Standard Therapy |
| Whole Breast Radiotherapysix and a half week treatment | Radiation | Standard Therapy |
| Intracavitary BrachytherapyAlso: MammoSite5 day treatment | Radiation | Accelerated Partial Breast Irradiation |
| Accelerated External Beam 3-D Conformal Radiotherapy5 day treatment | Radiation | Accelerated Partial Breast Irradiation |
| Stereotactic APBI4 day treatment | Radiation | Accelerated Partial Breast Irradiation |
Primary outcome
In-breast tumor recurrence (IBTR)
Time frame: 20 years
Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029
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 20 Mar 2026.
- Derived from this study: PubMed 27322859Horst KC, Fasola C, Ikeda D, Daniel B, Ognibene G, Goffinet DR, Dirbas FM. Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. Breast. 2016 Aug;28:178-83. doi: 10.1016/j.breast.2016.06.001. Epub 2016 Jun 17.
- 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.
Frederick M. Dirbas principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Operative Radiotherapy (IORT), Lumpectomy and Whole Breast Radiotherapy in people with Breast Cancer and Carcinoma, Ductal, run by Stanford University 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 3 inclusion and 15 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 20 Mar 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: 20 years). 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 NCT00185744, which also lists 1 linked publication.
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 20 Mar 2026.