Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00185744
• Other study ID #: IRB-13807
• Secondary ID: 78466BRSNSTU0003
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2002
• Est. completion date: March 2029

Study information

• Verified date: February 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: March 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Ductal

Intervention

Radiation:
• Intra-Operative Radiotherapy (IORT)
single dose in the operating room after lumpectomy

Procedure:
• Lumpectomy

Radiation:
• Whole Breast Radiotherapy
six and a half week treatment
• Intracavitary Brachytherapy
5 day treatment
• Accelerated External Beam 3-D Conformal Radiotherapy
5 day treatment
• Stereotactic APBI
4 day treatment

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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