Clinical trial · Interventional
Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer
- 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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven breast cancer * Metastatic disease OR * Locoregional relapse following optimal adjuvant therapy and regional treatment * HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 10 g/dL Hepatic: * SGOT and SGPT no greater than 3 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN unless documented to be arising from bone * Bilirubin no greater than 1.5 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Cardiovascular: * LVEF normal by radioisotope method * No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No known sensitivity to benzyl alcohol * No other prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * See Disease Characteristics Biologic therapy: * Not specified Chemotherapy: * No prior doxorubicin greater than 240 mg/m2 Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy to left breast or chest wall allowed Surgery: * Not specified
References
Publications (0)
Data not yet available