Clinical trial · Interventional
Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast
NCT00036998CI-TRIAL-00012530unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. PURPOSE: Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| thermal ablation therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary breast cancer by core needle biopsy * T1a, b, c, or T2 * Diagnosis not made with a lumpectomy or incisional biopsy * Candidate for breast conservation surgery (lumpectomy/radiotherapy) * Tumor measurable by breast ultrasound * No metastatic disease, including skin metastases * No bilateral breast cancer * No high-probability of extensive intraductal disease in situ * 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, INR, and PTT 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 * Creatinine less than 1.9 mg/dL * No renal insufficiency Cardiovascular: * No pacemakers or defibrillators * No clinically significant heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception, including 1 barrier method * Able to tolerate prone position and breast compression * No breast implants * No prior collagen vascular disease * No other factor or condition (other than tumor size) that would preclude lumpectomy * No mental condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics Other: * No prior participation in this study * More than 30 days since prior participation in another clinical study * No concurrent anticoagulants
References
Publications (0)
Data not yet available
No reference posted for this study.