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

Stage IB Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02927912
• Other study ID #: OSU-16106
• Secondary ID: NCI-2016-01294
• Status: Recruiting
• Phase: Phase 2
• Start date: October 16, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer

Intervention

Radiation:
• Electron Beam Therapy
Undergo IOERT boost

Procedure:
• Lumpectomy
Undergo lumpectomy

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Radiation:
• Radiation Therapy
Undergo whole breast radiation therapy

Procedure:
• Reconstructive Surgery
Undergo oncoplastic reconstruction

Locations

Country	Name	City	State
Canada	Centre Hospitalier de I'Universite de Montreal	Québec	Montreal
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University Hospitals	Cleveland	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Avera Cancer Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in self-reported cosmesis using the BCTOS	The mean and standard deviation of the self-reported cosmesis using the BCTOS cosmesis scale will be summarized over time. The change over time using a repeated measures model or non-parametric methods, if appropriate, will be examined.	Baseline up to 3 years
Secondary	Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs	physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs	Up to 3 years after completion of radiation therapy
Secondary	Quality of life assessed by Breast Cancer Treatment Outcome Scale	determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT	Up to 3 years after completion of radiation therapy
Secondary	Rate of ipsilateral breast tumor recurrence	The exact binomial confidence interval for the rate will be calculated.	At 5 years

External Links

•   The Jamesline