NCT02400658

Brief Summary

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
15mo left

Started Mar 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Mar 2015Sep 2027

Study Start

First participant enrolled

March 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

12.5 years

First QC Date

March 12, 2015

Last Update Submit

January 23, 2023

Conditions

Breast Cancer

Keywords

breast cancerearly-stageIORTbrachytherapy

Outcome Measures

Primary Outcomes (1)

  • Rate of Local Breast Tumor Recurrence

    Up to 60 Months After Treatment

Secondary Outcomes (8)

  • Rate of Ipsilateral Breast Tumor (Not Local) Recurrence

    Up to 60 Months After Treatment

  • Rate of Distant Recurrence of Breast Cancer

    Up to 60 Months After Treatment

  • Cancer Specific-Survival and Overall Survival Response Rate

    Minimum of 60 Months After Treatment

  • Changes in Reported Patient and Physician Cosmetic Descriptions

    Up to 60 Months After Treatment

  • Comparison of Pre-and Post Pathology Stratum

    Up to 60 Months After Treatment

  • +3 more secondary outcomes

Study Arms (1)

IORT with CT-Guided HDR Brachytherapy

EXPERIMENTAL

Patients will receive IORT with CT-guided HDR brachytherapy at the time of breast surgery.

Device: IORT with CT-Guided HDR Brachytherapy

Interventions

IORT with CT-Guided HDR BrachytherapyDEVICE

This therapy targets the cancer cells directly, reducing the volume of breast tissue exposed to the radiation and the risks involved with the radiation. CT imaging will be used via a multichannel/multi-dwell balloon catheter to better sculpt the cancer away from the heart, skin, and ribs.

Also known as: Surgery, Breast Lumpectomy
IORT with CT-Guided HDR Brachytherapy

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
  • Tumor size must be less than or equal to 3 cm.
  • Patient is 45 years of age or older.

You may not qualify if:

  • Male patients.
  • Pregnant patients.
  • Breast cancer that involves the skin or chest wall.
  • History of ipsilateral breast cancer.
  • Multicentric breast cancer in the ipsilateral breast.
  • Known BRCA gene mutation.
  • Patient with nodal disease.
  • Patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size.
  • Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hackensack Meridian Health - John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19147, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

  • Turkheimer LM, Petroni GR, Berger AC, Schroen AT, Brenin DR, Lazar M, Libby B, Janowski EM, Showalter TN, Showalter SL. Novel Form of Breast Intraoperative Radiation Therapy with CT-Guided High-Dose-Rate Brachytherapy: Interim Results of a Prospective Phase-II Clinical Trial. J Am Coll Surg. 2024 Jan 1;238(1):10-20. doi: 10.1097/XCS.0000000000000869. Epub 2023 Oct 23.

    PMID: 37870228DERIVED

  • Meneveau MO, Petroni GR, Varhegyi NE, Hulse JC, Schroen AT, Brenin DR, Janowski EM, Berger AC, Lazar MA, Simone NL, Showalter TN, Showalter SL. Toxicity and cosmetic outcomes after treatment with a novel form of breast IORT. Brachytherapy. 2020 Sep-Oct;19(5):679-684. doi: 10.1016/j.brachy.2020.05.002. Epub 2020 Jun 20.

    PMID: 32571746DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, OperativeMastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy

Study Officials

  • Shayna Showalter

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 27, 2015

Study Start

March 1, 2015

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

US(3)