Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Carcinoma, Ductal
• Interventions: Procedure: Lumpectomy; Radiation: Intra-Operative Radiotherapy (IORT); Radiation: Whole Breast Radiotherapy; Radiation: Intracavitary Brachytherapy; Radiation: Accelerated External Beam 3-D Conformal Radiotherapy; Radiation: Stereotactic APBI

• Registration Number: NCT00185744
• Lead Sponsor: Stanford University

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 available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated Partial Breast Irradiation	Stereotactic APBI	lumpectomy with accelerated partial breast irradiation
Standard Therapy	Lumpectomy	lumpectomy and whole breast irradiation
Accelerated Partial Breast Irradiation	Lumpectomy	lumpectomy with accelerated partial breast irradiation
Accelerated Partial Breast Irradiation	Intra-Operative Radiotherapy (IORT)	lumpectomy with accelerated partial breast irradiation
Accelerated Partial Breast Irradiation	Intracavitary Brachytherapy	lumpectomy with accelerated partial breast irradiation
Accelerated Partial Breast Irradiation	Accelerated External Beam 3-D Conformal Radiotherapy	lumpectomy with accelerated partial breast irradiation
Standard Therapy	Whole Breast Radiotherapy	lumpectomy and whole breast irradiation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States