Proton Accelerated Partial Breast Irradiation (APBI)

September 28, 2021 updated by: Teresa Meier, University of Cincinnati

Phase II Study to Evaluate the Cosmetic Outcome of Using Pencil Beam Scanning Proton Therapy for Accelerated Partial Breast Irradiation in Early Stage Breast Cancer

This prospective, non-randomized phase II study will evaluate the cosmetic outcome of using pencil beam scanning proton therapy for partial breast irradiation in patients diagnosed with early stage breast cancer. In addition the study will evaluate the acute and late toxicities, and the rates of ipsilateral breast tumor recurrence, both in situ and invasive disease.

To qualify for the trial, patients must be 50 years or older and have stage 0 (carcinoma in situ) or stage IA or IIA invasive carcinoma of the breast with no evidence of metastatic disease. The tumor size must be 3cm or less. Women must have undergone a partial mastectomy with margins free of invasive cancer and at least a 2mm margin for in situ disease. Patients must have clinically node negative disease. Patients with invasive disease must also have nodal assessment performed with either sentinel lymph node biopsy or axillary lymph node dissection and patients must have pathologically node negative disease. Accelerated partial breast irradiation (APBI) will utilize pencil beam scanning proton therapy. Partial breast irradiation will be delivered twice a day, at least 6 hours apart, over 5 treatment days.

This trial is designed to accrue 21 patients over a period of three years.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

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:

  • The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
  • Patients must be ≥ 50 years old.
  • Patients should have a life expectancy of at least 10 years taking into consideration comorbid conditions.
  • Surgical treatment of the breast must have been partial mastectomy. The margins of the resected specimen must be histologically free of tumor for invasive disease and with at least a 2mm margin for in situ disease. Reexcision of surgical margins is permitted to obtain negative margins. Postoperative mammogram of the surgical specimen or breast must be performed to confirm that all abnormal calcifications were removed at the time of surgery. Surgical clips must be placed at the partial mastectomy site by the surgeon at the time of excision.
  • Patients must have American Joint Committee on Cancer 8th edition pathology stage Tis, T1, or T2 and N0 as assessed by sentinel lymph node biopsy or axillary lymph node dissection for invasive disease. The tumor size must be 3cm or less in greatest dimension.
  • On histologic examination, the tumor must be ductal carcinoma in situ (low or intermediate grade), invasive ductal carcinoma (any grade), or invasive lobular carcinoma.
  • Patients must have unicentric disease with limited or focal lymphovascular space invasion (LVSI).
  • Patients must have an estrogen reception (ER) analysis performed and the primary tumor should be ER positive.
  • The target partial mastectomy cavity must be clearly delineated and the target partial mastectomy cavity/whole breast reference volume must be ≤ 30% based on the post- operative scan. The partial mastectomy cavity must be > 5mm from the skin. This can be confirmed at time of CT simulation for radiation treatment planning.
  • Patients must enroll within 42 days following the last surgery for breast cancer (partial mastectomy or re-excision of margins).
  • Proton APBI should start within 12 weeks from the time of surgery.

Exclusion Criteria:

  • Male
  • Patients < 50 years of age.
  • Tumor > 3cm in greatest dimension or American Joint Committee on Cancer 8th edition pathologic stage T3 or T4 or node positive disease.
  • If patients have invasive carcinoma and no nodal assessment was performed, specifically the patient did not undergo sentinel lymph node biopsy or axillary lymph node dissection.
  • Patients with persistently positive margins despite attempted re-excision.
  • Proven multicentric disease or extensive LVSI.
  • Clear delineation of the extent of the target partial mastectomy cavity is not possible.
  • Patients who have undergone oncoplastic reconstruction.
  • Any patients who received neoadjuvant chemotherapy or hormonal therapy prior to surgical excision of the tumor.
  • Any patients who require adjuvant chemotherapy following lumpectomy.
  • Patients whose primary tumor is ER negative.
  • Patients with high grade ductal carcinoma in situ.
  • Patients with known BRCA1 or BRCA2 mutation.
  • Prior breast or thoracic radiation and any prior breast surgery in the ipsilateral breast.
  • Patients with history of collagen vascular disease including scleroderma, lupus, polymyositis, or dermatomyositis.
  • Pregnancy.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Stage Breast Cancer
Patients to be treated with Accelerated Partial Breast Irradiation utilizing pencil beam scanning proton therapy. Treatment will be delivered twice a day, at least 6 hours apart, over 5 treatment days.
Radiation: Proton Accelerated Partial Breast Irradiation
38.5 Cobalt Gray Equivalent (CGE) given over 10 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic outcome (change in appearance as compared to untreated breast)
Time Frame: Through Study Completion, an average of 2 years
Breast Cancer Treatment Outcome Scale [8 (no difference) through 32 (large difference)]
Through Study Completion, an average of 2 years
Cosmetic outcome (change in appearance as compared to untreated breast)
Time Frame: Through Study Completion, an average of 2 years
Physician and Nurse Harvard Cosmesis Scale [1 (excellent) through 4 (poor)]
Through Study Completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of acute (within 3 months of treatment) toxicity
Time Frame: Through Study Completion, an average of 2 years
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Through Study Completion, an average of 2 years
Rates of late (> 3 months after treatment) toxicity
Time Frame: Through Study Completion, an average of 2 years
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Through Study Completion, an average of 2 years
Rate of ipsilateral breast tumor recurrence, including both in situ and invasive disease.
Time Frame: Through Study Completion, an average of 2 years
Presence of invasive or ductal carcinoma in-situ in ipsilateral breast as confirmed by biopsy
Through Study Completion, an average of 2 years
Rate of regional recurrence
Time Frame: Through Study Completion, an average of 2 years
Presence of tumor in the ipsilateral axillary, infraclavicular, supraclavicular or internal mammary lymph nodes.
Through Study Completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

University of Cincinnati

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

Helpful Links

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)

July 1, 2020

Primary Completion (Actual)

July 8, 2021

Study Completion (Actual)

July 8, 2021

Study Registration Dates

First Submitted

April 22, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Breast Cancer

Clinical Trials on Proton Accelerated Partial Breast Irradiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe