Clinical trial NCT02927912: Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
Official title: Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
timeFrame: Up to 30 days after surgery and IOERT boost
measure: Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
timeFrame: At 1 year from the end of therapy
Secondary outcomes:
measure: Change in self-reported cosmesis using the BCTOS
timeFrame: Baseline up to 3 years
measure: Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
timeFrame: Up to 3 years after completion of radiation therapy
measure: Quality of life assessed by Breast Cancer Treatment Outcome Scale
timeFrame: Up to 3 years after completion of radiation therapy
measure: Rate of ipsilateral breast tumor recurrence
timeFrame: At 5 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Québec
country: Canada
facility: Centre Hospitalier de I'Universite de Montreal
state: Montreal
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Jose Bazan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: