Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Stanford University

Status: Active, not recruiting

Conditions: Carcinoma, Ductal; Breast Cancer

Treatments: Radiation: Accelerated External Beam 3-D Conformal Radiotherapy; Procedure: Lumpectomy; Radiation: Stereotactic APBI; Radiation: Intra-Operative Radiotherapy (IORT); Radiation: Whole Breast Radiotherapy; Radiation: Intracavitary Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00185744

IRB-13807 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Accelerated Partial Breast Irradiation

Experimental group

Description:

lumpectomy with accelerated partial breast irradiation

Treatment:

Radiation: Intracavitary Brachytherapy

Radiation: Intra-Operative Radiotherapy (IORT)

Radiation: Stereotactic APBI

Procedure: Lumpectomy

Radiation: Accelerated External Beam 3-D Conformal Radiotherapy

Standard Therapy

Active Comparator group

Description:

lumpectomy and whole breast irradiation

Treatment:

Radiation: Whole Breast Radiotherapy

Procedure: Lumpectomy