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

NCT02927912 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-16106NCI-2016-01294
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0

  If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.

  Up to 30 days after surgery and IOERT boost

• Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales

  The proportion of patients with an overall response rate of grade 3 fibrosis at 1 year from the end of therapy along with the exact binomial confidence interval for the rate will be calculated.

  At 1 year from the end of therapy

Secondary Outcomes (4)

• Change in self-reported cosmesis using the BCTOS

  Baseline up to 3 years

• Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs

  Up to 3 years after completion of radiation therapy

• Quality of life assessed by Breast Cancer Treatment Outcome Scale

  Up to 3 years after completion of radiation therapy

• Rate of ipsilateral breast tumor recurrence

  At 5 years

Study Arms (1)

Treatment (IOERT boost)

EXPERIMENTAL

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.

Radiation: Electron Beam Therapy; Procedure: Lumpectomy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: Reconstructive Surgery

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (IOERT boost)

Questionnaire Administration OTHER

Ancillary studies

Treatment (IOERT boost)

Radiation Therapy RADIATION

Undergo whole breast radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RADIATION, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (IOERT boost)

Reconstructive Surgery PROCEDURE

Undergo oncoplastic reconstruction

Also known as: Reconstruction

Treatment (IOERT boost)

Electron Beam Therapy RADIATION

Undergo IOERT boost

Also known as: photon beam radiation therapy

Treatment (IOERT boost)

Lumpectomy PROCEDURE

Undergo lumpectomy

Also known as: Lumpectomy of Breast, Partial Mastectomy

Treatment (IOERT boost)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (5)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Centre Hospitalier de I'Universite de Montreal

Québec, Montreal, H2X0C1, Canada

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Radiotherapy; Radiation; Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Therapeutics; Physical Phenomena

Study Officials

• Jose Bazan, MD, MS

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: October 16, 2017
• Primary Completion: May 8, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)