Breast CancerPhase 2NCT00036985
Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer
A Phase 2 study testing cyclophosphamide, doxorubicin hydrochloride and conventional surgery in people with Breast Cancer, run by Imunon at 7 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cyclophosphamide, doxorubicin hydrochloride and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 7 sitesUnited States
- Study dates
- Aug 2001to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed locally advanced primary breast cancer
- Stage III (T2-3, N2-3) disease
- Diagnosis not made by lumpectomy or incisional biopsy
- Currently a candidate for mastectomy and neoadjuvant chemotherapy
- Primary tumor measurable by breast ultrasound and clinical exam
- No bilateral breast cancer
- No high probability for extensive intraductal in situ disease
- No clinical fixation to the pectoralis major muscle or skin
- No involvement of the nipple
- No inflammatory breast cancer
- No multicentric disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 6 months
Hematopoietic:
- Platelet count at least 100,000/mm^3 (no thrombocytopenia)
- No bleeding disorders
Hepatic:
- PT and PTT less than 1.5 times normal
- INR less than 1.5 times normal
- Bilirubin no greater than 2.0 mg/dL
- Transaminases no greater than 2 times normal
- No coagulopathy
- No liver disease
Renal:
- BUN less than 30 mg/dL OR
- Creatinine less than 1.9 mg/dL
- No renal insufficiency
Cardiovascular:
- No clinically significant heart disease
- No pacemakers or defibrillators
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception
- No breast implants
- No prior collagen vascular disease
- No concurrent mental condition that would preclude study
- No contraindications to chemotherapy
- Able to tolerate prone position and breast compression
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- No prior participation in this study
- More than 30 days since participation in another clinical trial
- No concurrent participation in another clinical trial
- No concurrent anticoagulants
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Comprehensive Breast Center of Coral Springs
Coral Springs, Florida, 33071
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Mroz-Baier Breast Care Center
Memphis, Tennessee, 38119
Breast Care Specialists, P.C.
Norfolk, Virginia, 23510
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, 92868
Study site
Tacoma, Washington, 98405
About this study
Official title: A Randomized Pivotal Clinical Trial To Assess The Efficacy Of Pre-operative Focused Microwave Thermotherapy Treatment Combined With Pre-operative Chemotherapy For Cytoreduction Of Advanced Breast Cacer In Intact Breast
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining chemotherapy with microwave thermotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with or without microwave thermotherapy before surgery in treating women who have locally advanced breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the safety and efficacy of neoadjuvant therapy comprising cytoreductive doxorubicin and cyclophosphamide with or without focused microwave thermotherapy in women with locally advanced breast cancer in an intact breast.
- Evaluate percentage of patients who achieve at least 85% pathological cell death after treatment with focused microwave thermotherapy.
- Compare clear pathology tumor margins and reduction of second incision rates in patients treated with these regimens.
- Compare the amount of surgically removed breast and tumor tissue in patients treated with these regimens.
- Compare the measurement of the extent of tumor margins in patients treated with these regimens.
- Compare the reduction of tumor size in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor size (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV over 15 minutes and doxorubicin IV over 15 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.
During courses 1 and 2 only, patients undergo focused microwave thermotherapy on day 1 of chemotherapy (or within 36 hours after chemotherapy). Patients undergo ultrasound-guided placement of a microwave sensor and a temperature probe (before or after compression of the breast) and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast. Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue. In the absence of any unacceptable toxicity, a target tumor temperature of 43-47° C is reached and maintained for an equivalent thermal dose of 80-120 minutes.
- Arm II: Patients receive chemotherapy only as in arm I. Within 60 days after completion of thermochemotherapy or chemotherapy alone, patients in both arms undergo total mastectomy, partial mastectomy, or other breast-conserving surgery, as appropriate. At the discretion of the physician, beginning after completion of chemotherapy, patients in both arms who are estrogen receptor positive may receive oral tamoxifen. Within 4 weeks after completion of chemotherapy and surgery, eligible patients in both arms also undergo radiotherapy to the breast and lymph nodes.
Patients are followed at 30 and 90 days.
PROJECTED ACCRUAL: A total of 280-312 patients (140-156 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- cyclophosphamide, doxorubicin hydrochloride, conventional surgery, neoadjuvant therapy, thermal ablation therapy
- Keywords
- stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
thermal ablation therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Imunon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William E. Gannon, MD, Study chair, Imunon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036985
- Sponsor's protocol ID
- CDR0000069346
- Other IDs
- CELSION-10200201, OU-09533
- Status last verified
- Jul 2004
- First submitted
- 13 May 2002
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pivotal Clinical Trial To Assess The Efficacy Of Pre-operative Focused Microwave Thermotherapy Treatment Combined With Pre-operative Chemotherapy For Cytoreduction Of Advanced Breast Cacer In Intact Breast
- ClinicalTrials.gov ID
- NCT00036985
- Acronym / sponsor ID
- CDR0000069346
- Conditions
- Breast Cancer
- Keywords
- stage IIIA breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- ImunonIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining chemotherapy with microwave thermotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with or without microwave thermotherapy before surgery in treating women who have locally advanced breast cancer.
Detailed description
OBJECTIVES:
- Compare the safety and efficacy of neoadjuvant therapy comprising cytoreductive doxorubicin and cyclophosphamide with or without focused microwave thermotherapy in women with locally advanced breast cancer in an intact breast.
- Evaluate percentage of patients who achieve at least 85% pathological cell death after treatment with focused microwave thermotherapy.
- Compare clear pathology tumor margins and reduction of second incision rates in patients treated with these regimens.
- Compare the amount of surgically removed breast and tumor tissue in patients treated with these regimens.
- Compare the measurement of the extent of tumor margins in patients treated with these regimens.
- Compare the reduction of tumor size in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor size (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV over 15 minutes and doxorubicin IV over 15 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.
During courses 1 and 2 only, patients undergo focused microwave thermotherapy on day 1 of chemotherapy (or within 36 hours after chemotherapy). Patients undergo ultrasound-guided placement of a microwave sensor and a temperature probe (before or after compression of the breast) and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast. Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue. In the absence of any unacceptable toxicity, a target tumor temperature of 43-47° C is reached and maintained for an equivalent thermal dose of 80-120 minutes.
- Arm II: Patients receive chemotherapy only as in arm I. Within 60 days after completion of thermochemotherapy or chemotherapy alone, patients in both arms undergo total mastectomy, partial mastectomy, or other breast-conserving surgery, as appropriate. At the discretion of the physician, beginning after completion of chemotherapy, patients in both arms who are estrogen receptor positive may receive oral tamoxifen. Within 4 weeks after completion of chemotherapy and surgery, eligible patients in both arms also undergo radiotherapy to the breast and lymph nodes.
Patients are followed at 30 and 90 days.
PROJECTED ACCRUAL: A total of 280-312 patients (140-156 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| thermal ablation therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E. Gannon, MD study chair
Imunon
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclophosphamide, doxorubicin hydrochloride and conventional surgery in people with Breast Cancer, run by Imunon at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.