Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Stage IIA Breast Cancer

Stage IA Breast Cancer

Treatments

Other: Laboratory Biomarker Analysis

Radiation: Intraoperative Radiation Therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01570998

NCI-2017-00461 (Registry Identifier)

117515

Details and patient eligibility

About

This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

Full description

PRIMARY OBJECTIVES:

I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol.

II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients.

III. To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation, as indicated by pathologic risk factors, in women with early stage breast cancer.

IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival.

OUTLINE:

Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.

After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.

Enrollment

1,500 estimated patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Suitable for breast conserving surgery
T1 and T2 (< 3.5 cm), N0, M0

Exclusion criteria

Axillary lymph node positive breast cancer
Tumor size > 3.5 cm
Extensive intraductal component (EIC >= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen
Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
Inability to assess pathologic margin status
Synchronous bilateral breast cancer at the time of diagnosis
Ipsilateral breast had a previous cancer and/or prior in-field radiation
Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required)
Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
Any factor included as exclusion criteria in the participating center's treatment policy statement
Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):
- Patients under the age of 50
- Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
- Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
- Lymphovascular invasion
- High grade
- Tumors > 3 cm
- Node positive patients
- Prior chemotherapy or hormone therapy