Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

February 22, 2023 updated by: Stanford University
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ
  2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
  3. Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.

Exclusion Criteria:

  1. Men
  2. Prior malignancy, breast or other if metastatic or with anticipated survival of < 5 years
  3. Pregnant women
  4. Immunocompromised
  5. Poorly controlled insulin dependent diabetes
  6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
  7. Breast cancer that involves skin or chest wall
  8. Multifocal or Multicentric breast cancer
  9. Invasive lobular carcinoma
  10. Diffuse microcalcifications on mammography
  11. Invasive carcinoma with extensive intraductal component (EIC)
  12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
  13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
  14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
  15. Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Accelerated Partial Breast Irradiation
lumpectomy with accelerated partial breast irradiation
Radiation: Intra-Operative Radiotherapy (IORT)
single dose in the operating room after lumpectomy
Procedure: Lumpectomy
Radiation: Intracavitary Brachytherapy
5 day treatment
Other Names:
  • MammoSite
Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
5 day treatment
Radiation: Stereotactic APBI
4 day treatment
Active Comparator: Standard Therapy
lumpectomy and whole breast irradiation
Procedure: Lumpectomy
Radiation: Whole Breast Radiotherapy
six and a half week treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Frederick M. Dirbas, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Anticipated)

March 1, 2029

Study Completion (Anticipated)

March 1, 2029

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-13807 (Other Identifier: Stanford IRB)
  • 78466 (Other Identifier: Old IRB Protocol ID)
  • BRSNSTU0003 (Other Identifier: OnCore)
  • NCT00185744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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