Back to resultsAccelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Primary Purpose
Breast Cancer, Carcinoma, Ductal
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intra-Operative Radiotherapy (IORT)
Lumpectomy
Whole Breast Radiotherapy
Intracavitary Brachytherapy
Accelerated External Beam 3-D Conformal Radiotherapy
Stereotactic APBI
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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)
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Accelerated Partial Breast Irradiation
Standard Therapy
Arm Description
lumpectomy with accelerated partial breast irradiation
lumpectomy and whole breast irradiation
Outcomes
Primary Outcome Measures
In-breast tumor recurrence (IBTR)
Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029
Secondary Outcome Measures
Full Information
NCT ID
NCT00185744
First Posted
September 12, 2005
Last Updated
February 22, 2023
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT00185744
Brief Title
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Official Title
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2002 (undefined)
Primary Completion Date
March 2029 (Anticipated)
Study Completion Date
March 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Carcinoma, Ductal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Accelerated Partial Breast Irradiation
Arm Type
Experimental
Arm Description
lumpectomy with accelerated partial breast irradiation
Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
lumpectomy and whole breast irradiation
Intervention Type
Radiation
Intervention Name(s)
Intra-Operative Radiotherapy (IORT)
Intervention Description
single dose in the operating room after lumpectomy
Intervention Type
Procedure
Intervention Name(s)
Lumpectomy
Intervention Type
Radiation
Intervention Name(s)
Whole Breast Radiotherapy
Intervention Description
six and a half week treatment
Intervention Type
Radiation
Intervention Name(s)
Intracavitary Brachytherapy
Other Intervention Name(s)
MammoSite
Intervention Description
5 day treatment
Intervention Type
Radiation
Intervention Name(s)
Accelerated External Beam 3-D Conformal Radiotherapy
Intervention Description
5 day treatment
Intervention Type
Radiation
Intervention Name(s)
Stereotactic APBI
Intervention Description
4 day treatment
Primary Outcome Measure Information:
Title
In-breast tumor recurrence (IBTR)
Description
Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029
Time Frame
20 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick M. Dirbas
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27322859
Citation
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.
Results Reference
derived
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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
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