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Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors

NCT01204801 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2015-09-24

No results posted yet for this study

Summary

The purpose of this randomized Phase III study is to determine whether preoperative focused microwave heat treatment and chemotherapy combined are more effective than preoperative chemotherapy alone in the treatment of large breast cancer tumors in the intact breast. Combining heat with chemotherapy before surgery might shrink the tumor so that it can be removed in a breast conserving surgery (lumpectomy) instead of a mastectomy.

Conditions

Interventions

DEVICE

Focused Microwave Thermotherapy

Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs + Thermotherapy. Thermotherapy at first 3 chemotherapy treatments for Anthracycline chemotherapy nominally every 21±7 days plus Standard of Care chemotherapy. (A targeted tumor temperature of 44ºC (plus or minus 1.5ºC) and a targeted thermal dose of 80 equivalent treatment minutes (plus or minus 20 treatment minutes)). In the event that the targeted minimum cumulative thermal dose of 180 equivalent treatment minutes is not achieved in the first three treatments, an optional fourth thermotherapy treatment may be administered in combination with the fourth course of Anthracycline and standard of care chemotherapy. Standard of care (including breast imaging, drugs, and radiation) will be provided to all eligible subjects during and following the above study treatments.

DRUG

Chemotherapy (control)

Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs. Anthracycline chemotherapy nominally every 21±7 days. Standard of care (including breast imaging, drugs, and radiation) will be provided to all eligible subjects during and following the above study treatments.

Sponsors & Collaborators

  • Medifocus, Inc.

    lead INDUSTRY

Principal Investigators

  • William C. Dooley, MD · University of Oklahoma

  • John Keyserlingk, MD · Centre Medical Ville-Marie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT01204801 on ClinicalTrials.gov