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NCT Number: NCT00185744

Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intra-Operative Radiotherapy (IORT)

Radiation

single dose in the operating room after lumpectomy

Lumpectomy

Procedure

Whole Breast Radiotherapy

Radiation

six and a half week treatment

intracavitary brachytherapy

Radiation

5 day treatment

Other names: MammoSite

Accelerated External Beam 3-D Conformal Radiotherapy

Radiation

5 day treatment

Stereotactic APBI

Radiation

4 day treatment

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2002
Primary completion
2029
Study completion
2029
First posted
Sep 16, 2005
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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