Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction

The Ohio State University

Status and phase

Active, not recruiting

Phase 2

Conditions

Stage IB Breast Cancer

Stage IIB Breast Cancer

Stage IIA Breast Cancer

Stage IA Breast Cancer

Treatments

Radiation: Electron Beam Therapy

Other: Questionnaire Administration

Procedure: Reconstructive Surgery

Procedure: Lumpectomy

Radiation: Radiation Therapy

Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT02927912

OSU-16106

NCI-2016-01294 (Registry Identifier)

Details and patient eligibility

About

This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.

Full description

PRIMARY OBJECTIVES:

I. To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost followed by adjuvant whole breast radiotherapy.

SECONDARY OBJECTIVES:

I. To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire.

III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs.

OUTLINE:

Patients undergo standard of care lumpectomy and then undergo 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.

After completion of study treatment, patients are followed up at 1 month, 6 months, 1 year, and every year thereafter for 5 years.

Enrollment

108 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pathologically proven diagnosis of breast cancer
Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
- Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
Absolute neutrophil count > 1800 cells/cubic mm
Platelets >= 75,000 cells/cubic mm
Hemoglobin >= 8 g/dL
Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
Patients must provide study specific informed consent prior to study entry

Exclusion criteria

Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
Two or more cancers not resectable through a single lumpectomy incision
Bilateral breast cancer
Ductal breast carcinoma in situ (DCIS) only
Non-epithelial breast malignancies such as sarcoma/lymphoma
Male breast cancer
Paget's disease of the nipple
Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

108 participants in 1 patient group

Treatment (IOERT boost)

Experimental group

Description: