Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors (Medifocus301)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medifocus, Inc.
Sponsor:
Information provided by (Responsible Party):
Medifocus, Inc.
ClinicalTrials.gov Identifier:
NCT01204801
First received: August 26, 2010
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Device: Focused Microwave Thermotherapy
Drug: Chemotherapy (control)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Pivotal Trial to Assess the Safety and Efficacy of Preoperative Focused Microwave Thermotherapy Plus Preoperative Chemotherapy Versus Preoperative Chemotherapy Alone for Cytoreduction of Large Breast Cancer in Female Patients With Intact Breast

Resource links provided by NLM:


Further study details as provided by Medifocus, Inc.:

Primary Outcome Measures:
  • Tumor Shrinkage (ultrasound) [ Time Frame: Prior to Surgery, on average 4 months from the start of treatment ] [ Designated as safety issue: No ]
    Evaluate the efficiency of preoperative focused microwave thermotherapy as an adjunct to chemotherapy to increase the ultrasound-measured absolute mean tumor percent shrinkage by volume over that achieved by SOC preoperative chemotherapy.


Secondary Outcome Measures:
  • Conversion Rate to Breast Conservation (surgeon recommended) [ Time Frame: Prior to Mastectomy Recommendation, on average 4 months from the start of treatment ] [ Designated as safety issue: No ]
    Evaluate the potential benefits of this combination treatment to increase the absolute rate for which the surgeon can recommend breast conservation (lumpectomy or partial mastectomy) over that achieved using standard of care preoperative chemotherapy alone.

  • Tumor Shrinkage (Clinical) [ Time Frame: Prior to Surgery, on average 4 months from the start of treatment ] [ Designated as safety issue: No ]
    Evaluate the potential benefits of this combination treatment to increase the clinical (caliper-measured) absolute mean tumor shrinkage by area over that achieved by SOC preoperative chemotherapy

  • Tumor Shrinkage (Mammography) [ Time Frame: Prior to Surgery, on average 4 months from the start of treatment ] [ Designated as safety issue: No ]
    Evaluate the potential benefits of the combination treatment to increase the absolute mean tumor shrinkage by area on mammography over the achieved by SOC preoperative chemotherapy

  • Tumor Shrinkage (MRI) [ Time Frame: Prior to Surgery, on average 4 months from the start of treatment ] [ Designated as safety issue: No ]
    Evaluate the potential benefits of this combination treatment to increase the absolute mean tumor shrinkage by volume based on magnetic resonance imaging (MRI) over that achieved by SOC preoperative chemotherapy.

  • Tumor Necrosis (pathology) [ Time Frame: After Surgery, on average 5 months from the start of treatment ] [ Designated as safety issue: No ]
    Evaluate the potential benefits of this combination treatment to increase the absolute mean percent localized pathologic tumor cell kill by volume over that achieved by SOC preoperative chemotherapy.


Estimated Enrollment: 238
Study Start Date: November 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thermochemotherapy
Preoperative 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.
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.
Other Names:
  • APA-1000 Focused Microwave Thermotherapy Device
  • Adriamycin
Active Comparator: Chemotherapy (control)
Preoperative Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs
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.
Other Name: Adriamycin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must fulfill all of the following criteria to be eligible to participate in the study unless a specific waiver is requested by the investigator, agreed to by the sponsor, and documented for the study records. This protocol does not supersede Institutional IRB requirements for patient eligibility.

    1. Female subject must be 18 years of age or older.
    2. Subject must have adequate cognitive function to understand and sign the IRB/EC - approved informed consent prior to the performance of any study-specific procedure.
    3. The subject must be at no risk for pregnancy either postmenopausal for at least one year, surgically sterile (i.e. hysterectomy), using two forms of birth control one being barrier method or practicing abstinence throughout the length of the study. The subject must also have a negative serum pregnancy test prior to any study-specific procedure.
    4. Subject must have diagnosis by core biopsy of primary breast cancer, invasive ductal carcinoma or invasive lobular carcinoma, clinical tumor size 3.5 cm or greater, tumor classification T2 or T3, clinically node positive (N1, N2) or node negative (N0) by clinical exam, CT scan, or ultrasound, with distant metastasis (M1) or without distant metastasis (M0), with an indication for mastectomy.
    5. Primary tumor must be measurable on breast ultrasound (US).
    6. Primary tumor must be measurable by clinical exam.
    7. Subject is a candidate for mastectomy and is eligible for neoadjuvant treatment.
    8. Subject is a candidate for preoperative anthracycline-based combination chemotherapy.
    9. Subject has a life expectancy of 6 months or more.
    10. Karnofsky Score > 70.

Exclusion Criteria:

  • Subjects meeting any of the following criteria will be excluded from the study unless a specific waiver is requested by the investigator, agreed to by the sponsor, and documented appropriately for the study records. This protocol does not supersede Institutional IRB requirements for patient eligibility:

    1. Pregnant or lactating subject.
    2. Mentally unable to participate in the study successfully because they are unable to understand the informed consent or unable to comply with the required study procedures.
    3. Currently has breast implants.
    4. Bilateral breast cancer.
    5. Subjects with malignant breast tumors other than invasive ductal or invasive lobular carcinomas.
    6. Subject is a candidate for breast conservation at enrollment.
    7. Unable to tolerate prone position or breast compression.
    8. Clinically significant heart disease, pacemakers, or defibrillators.
    9. Bleeding disorders. Laboratory evidence of coagulopathy (PT, INR > 1.5; PTT > 1.5) or those who are receiving anticoagulants.
    10. Thrombocytopenia (platelet count less than 100,000/mm3).
    11. Renal insufficiency (BUN > 30 mg/dlan/or serum creatinine > 1.9 mg/dl).
    12. Liver disease (bilirubin > 2.0 mg/dl and or > 2 fold increase of transaminases).
    13. Diagnosis of cancer made by lumpectomy or incisional biopsy.
    14. Contraindications to chemotherapy.
    15. Clinical tumor fixation to the pectoralis major muscle or presence of skin nodules, involvement of the nipple.
    16. Breast cancer with a high probability of extensive intra-ductal in situ disease (extensive DCIS or LCIS).
    17. Multicentric disease (no satellite tumors greater than 2 cm diameter and no greater than 1.5 cm from the primary tumor as measured from the edge of the satellite tumor to the nearest edge of the primary tumor).
    18. Prior history of collagen vascular disease.
    19. Previous participation in Celsion Corporation study 201 or 202.
    20. Subject has participated in an investigation drug or device trial 30 days prior to the screening visit or plans to enroll in an investigational drug or device trial at any time during this study. However current participation in another clinical study involving imaging is not exclusion.
    21. Subject has a history of drug or alcohol abuse in the last 12 months.
    22. Non-glandular breast cancers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204801

Locations
United States, Oklahoma
Dr. William Dooley Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Deborah Moorad-Watts    405-271-2090    Deborah-Moorad-Watts@ouhsc.edu   
Principal Investigator: William C Dooley, MD         
Canada, Quebec
Ville-Marie Medical Centre Recruiting
Montreal, Quebec, Canada, H3G 1L5
Contact: John R Keyserlingk, MD    (514)933-2778 ext 260    jkeyserlingk@vmmed.com   
Sponsors and Collaborators
Medifocus, Inc.
Investigators
Principal Investigator: William C. Dooley, MD University of Oklahoma
Principal Investigator: John Keyserlingk, MD Centre Medical Ville-Marie
  More Information

Publications:
Responsible Party: Medifocus, Inc.
ClinicalTrials.gov Identifier: NCT01204801     History of Changes
Other Study ID Numbers: 102-00-301
Study First Received: August 26, 2010
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Medifocus, Inc.:
Breast Diseases
Cancer
Breast Cancer
Breast Tumor
Breast Neoplasm
Neoplasms by Site
Neoplasms
Breast Conserving Surgery
Breast Conservation
Partial Mastectomy
Lumpectomy
Mastectomy
Surgery
Neoadjuvant Therapy
Primary Therapy
Neoadjuvant Systemic Therapy
Thermotherapy
Fever Therapy
Hot Temperature
Hyperthermia
Hyperthermia, Therapeutic
Hyperthermia, Local
Hyperthermia, Induced
Therapeutic Hyperthermia
Microwave
Focused Microwave
Focused Microwave Thermotherapy
Minimally Invasive
Doxorubicin
Epirubicin

Additional relevant MeSH terms:
Breast Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Doxorubicin
Epirubicin
Liposomal doxorubicin
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014