Clinical trial · Interventional
Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer
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
- 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: 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.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| 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 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
References
Publications (0)
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