Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celsion
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin

Criteria

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