Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

NCT00185744 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IRB-13807
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Carcinoma, Ductal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Lumpectomy PROCEDURE

Accelerated Partial Breast Irradiation; Standard Therapy

Intra-Operative Radiotherapy (IORT) RADIATION

single dose in the operating room after lumpectomy

Accelerated Partial Breast Irradiation

Whole Breast Radiotherapy RADIATION

six and a half week treatment

Standard Therapy

Intracavitary Brachytherapy RADIATION

5 day treatment

Also known as: MammoSite

Accelerated Partial Breast Irradiation

Accelerated External Beam 3-D Conformal Radiotherapy RADIATION

5 day treatment

Accelerated Partial Breast Irradiation

Stereotactic APBI RADIATION

4 day treatment

Accelerated Partial Breast Irradiation

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 27322859 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal

Interventions

Mastectomy, Segmental; Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Radiotherapy; Therapeutics

Study Officials

• Frederick M. Dirbas

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2002
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)