Accelerated Partial Breast Irradiation Following Lumpecto... | NCT00185744

Studies
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

NCT00185744

Sponsor

Stanford University

Status

Active, not recruiting

Last Update Posted

Mar 20, 2026Actual

Enrollment

121Actual

Phase

Not Applicable

Conditions

Breast Cancer
Carcinoma, Ductal

Interventions

Intra-Operative Radiotherapy (IORT)
Lumpectomy
Whole Breast Radiotherapy
Intracavitary Brachytherapy
Accelerated External Beam 3-D Conformal Radiotherapy
Stereotactic APBI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Mar 2029Estimated

Completion Date

Mar 2029Estimated

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Accelerated Partial Breast Irradiation	Experimental	lumpectomy with accelerated partial breast irradiation	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	Procedure: Lumpectomy Radiation: Whole Breast Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intra-Operative Radiotherapy (IORT)	Radiation	single dose in the operating room after lumpectomy	Accelerated Partial Breast Irradiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-breast tumor recurrence (IBTR)	Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029	20 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Frederick M. Dirbas	Stanford University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27322859	Derived	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.

ID	Term
D001943	Breast Neoplasms
D044584	Carcinoma, Ductal

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D018299	Neoplasms, Ductal, Lobular, and Medullary

ID	Term
D015412	Mastectomy, Segmental
D001918	Brachytherapy

ID	Term
D008408	Mastectomy
D013514	Surgical Procedures, Operative
D011878	Radiotherapy
D013812	Therapeutics