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Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery

NCT02526498 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-05-15

Study results available
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Summary

This phase II trial studies how well accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type of internal radiation therapy that provides radiation inside the breast to any remaining tumor cells next to the space where the tumor was removed, and is given over a shorter amount of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is delivered to the tumor cells.

Conditions

  • Ductal Breast Carcinoma In Situ
  • Estrogen Receptor Positive
  • Invasive Breast Carcinoma
  • Progesterone Receptor Positive
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage IIA Breast Cancer

Interventions

RADIATION

Accelerated Partial Breast Irradiation

Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy

RADIATION

High-Dose Rate Brachytherapy

Undergo APBI using HDR brachytherapy

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Rutgers Cancer Institute of New Jersey

    collaborator OTHER

  • Cianna Medical, Inc.

    collaborator INDUSTRY

  • Elekta Limited

    collaborator INDUSTRY

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Bruce Haffty, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-15
Primary Completion
2017-08-18
Completion
2021-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526498 on ClinicalTrials.gov