Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen for patIents With Favorable Risk breaSt cancEr (APBI RISE)

November 11, 2022 updated by: Ryan K Nowak, MD, Sanford Health

SH APBI RISE: Evaluating the Safety and Efficacy of a Novel IMRT/VMAT-based Accelerated Partial Breast Irradiation Regimen for patIents With Favorable Risk breaSt cancEr

This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective interventional cohort study in breast cancer participants. The purpose of this study is to track physician-assessed cosmetic outcomes as the primary study endpoint, and compare these results to historical trials in which women with favorable risk early stage breast cancer underwent a course of adjuvant WBI.

Study Type

Interventional

Enrollment (Anticipated)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ability to provide informed written consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 or a Karnofsky performance score of ≥ 30%.
  • Willingness to return to Sanford Cancer Center for follow-up.
  • Radiation therapy is planned as part of routine care.
  • On histological examination, the tumor must be either ductal carcinoma in-situ (DCIS) or an invasive ductal carcinoma of the breast.
  • Patients must be ≥ 50 years old.
  • Presence of unifocal tumor.
  • Surgical treatment of the breast must have been a lumpectomy. Placement of surgical clips to delineate the lumpectomy bed is highly recommended, though not required.
  • The final margins of the resected specimen must be histologically free of tumor (≥ 2 mm for invasive adenocarcinoma and ≥ 3 mm for DCIS). Re-excision of surgical margins is permitted. Gross disease must be unifocal with a pathologic invasive tumor size tumor size ≤ 2.0 cm or pathologic DCIS size ≤ 2.5 cm.
  • Patients with invasive breast cancer are required to have axillary staging consisting of a sentinel lymph node biopsy. The sentinel lymph node(s) must be negative for regionally metastatic disease, both on routine H&E evaluation and immunohistochemical staining. Axillary staging is not required for patients with DCIS.
  • Absence of lymphovascular space invasion.
  • The tumor must be positive for either the presence of the estrogen or progesterone receptor, and either 0 or +1 for the HER-2/neu receptor on immunohistochemical staining.
  • The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity to the whole breast reference volume ratio must be ≤ 30% based on the CT-simulation scan.
  • Life expectancy of 5 years or longer excluding breast cancer diagnosis(co-morbid conditions taken into considerations by the PI)
  • Women of child-bearing potential must have a negative pregnancy test before their CT simulation, and must agree to use an effective method of birth control during their radiation therapy treatment course.

Exclusion Criteria:

  • Pregnant women, or women of childbearing potential who are unwilling to employ adequate contraception.
  • Nuclear grade 3 DCIS or Nottingham grade 3 invasive ductal carcinoma.
  • Invasive lobular carcinoma, any grade.
  • Male sex.
  • Any treatment with radiation therapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study enrollment
  • Prior breast or thoracic radiation treatment for any reason.
  • History of prior invasive breast cancer or DCIS. (Patients with a history of LCIS treated by surgery alone are eligible.)
  • Paget's disease of the nipple.
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  • Patients with a collagen vascular disease; specifically, SLE or scleroderma.
  • Breast implants. (Patients who have had implants removed are eligible.)
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  • Women with a known or suspected predisposition to developing breast cancer (i.e., BRCA1/2 mutations, p53 mutation, etc...)
  • Women who are pregnant, or women of child-bearing potential who refuse to use an effective method of birth control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IMRT/VMAT-Based Accelerated Partial Breast Irradiation
Patients will be treated with a novel IMRT/VMAT-based accelerated partial breast irradiation regimen.
Radiation: IMRT/VMAT-Based Accelerated Partial Breast Irradiation
The lumpectomy bed will receive a total of 26 Gy in 5 fractions, with 1 fraction delivered per day. Ideally, the course of radiation therapy would be completed over 5 consecutive treatment days. Treatment must begin within 12 weeks of lumpectomy or re-excision of surgical margins and must be completed within 10 calendar days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician-Assessed Adverse Breast Cosmesis
Time Frame: 3 Years
To evaluate the incidence of physician-assessed adverse breast cosmesis by utilizing the Harvard Breast Cosmesis survey. The survey scores breast cosmesis from 1 to 4, with 1 representing "excellent" cosmesis, 2 representing "good" cosmesis, 3 representing "fair" cosmesis, and 4 representing "poor" cosmesis. Adverse breast cosmesis is defined as a score of either 3 or 4 on the Harvard Breast Cosmesis survey.
3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Rate
Time Frame: 3 Years
To evaluate the cumulative incidence of ipsilateral breast tumor recurrence, regional nodal recurrence, and distant recurrence by following participants after treatment with yearly mammograms and breast exams performed during routine clinic appointments.
3 Years
Disease Free Survival Rate
Time Frame: 3 Years
To evaluate disease free survival and overall survival by following participants after treatment with yearly mammograms and breast exams performed during routine clinic appointments.
3 Years
Acute Adverse Events
Time Frame: 12 Weeks
To evaluate the incidence and severity of acute adverse events associated with our novel IMRT/VMAT-based APBI regimen, using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 grading system. The CTCAE Version 5.0 grading system scores adverse events from 1 to 5, with higher scores representing more severe adverse events.
12 Weeks
Late Adverse Events
Time Frame: 3 Years
To evaluate the incidence and severity of late adverse events associated with our novel IMRT/VMAT-based APBI regimen, using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 grading system. The CTCAE Version 5.0 grading system scores adverse events from 1 to 5, with higher scores representing more severe adverse events.
3 Years
Patient Quality of Life
Time Frame: 3 Years
To evaluate patient quality of life associated with our novel IMRT/VMAT-based APBI regimen by using the breast cancer treatment outcome scale (BCTOS). The BCTOS contains 22 items, which are assigned to three internally consistent subscales: 1) Functional Status, 2) Aesthetic Status, and 3) Breast Sensitivity Status. Patients are instructed to rate each item of the BCTOS on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference, 4 = large difference). The score for each subscale is the mean of the ratings over all items belonging to that subscale. A higher score reflects a poorer status (i.e. a larger difference between the treated and the untreated breast). The survey also allows patients to address their satisfaction with their breast cancer treatment and results.
3 Years
Patient-Assessed Adverse Breast Cosmesis
Time Frame: 3 Years
To evaluate the incidence of patient-assessed adverse breast cosmesis by utilizing the Harvard Breast Cosmesis survey. The survey scores breast cosmesis from 1 to 4, with 1 representing "excellent" cosmesis, 2 representing "good" cosmesis, 3 representing "fair" cosmesis, and 4 representing "poor" cosmesis. Adverse breast cosmesis is defined as a score of either 3 or 4 on the Harvard Breast Cosmesis survey.
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Collaborators

University of North Dakota

Investigators

  • Principal Investigator: Ryan Nowak, MD, Sanford Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2022

Primary Completion (ANTICIPATED)

March 31, 2024

Study Completion (ANTICIPATED)

March 31, 2027

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (ACTUAL)

October 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH APBI RISE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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