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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (IOERT boost)

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

Group Type EXPERIMENTAL

Electron Beam Therapy

Intervention Type RADIATION

Undergo IOERT boost

Lumpectomy

Intervention Type PROCEDURE

Undergo lumpectomy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Radiation Therapy

Intervention Type RADIATION

Undergo whole breast radiation therapy

Reconstructive Surgery

Intervention Type PROCEDURE

Undergo oncoplastic reconstruction

Interventions

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Electron Beam Therapy

Undergo IOERT boost

Intervention Type RADIATION

Lumpectomy

Undergo lumpectomy

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Radiation Therapy

Undergo whole breast radiation therapy

Intervention Type RADIATION

Reconstructive Surgery

Undergo oncoplastic reconstruction

Intervention Type PROCEDURE

Other Intervention Names

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photon beam radiation therapy Lumpectomy of Breast Partial Mastectomy Quality of Life Assessment Cancer Radiotherapy Irradiate Irradiated Irradiation RADIATION Radiotherapeutics Radiotherapy RT Therapy, Radiation Reconstruction

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No