Clinical trial · Interventional
Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
Phase I/II Study of TLC D-99 Plus Herceptin as First or Second Line Therapy for Patients With Locally Advanced Inflammatory or Metastatic 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 so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have locally advanced, inflammatory, or metastatic 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 or cytologically confirmed locally advanced, inflammatory, or metastatic adenocarcinoma of the breast that has been treated with no more than 1 prior systemic cytotoxic regimen * Overexpression of HER2 protein (2+ or 3+) * Evaluable disease * History of brain metastases allowed if off steroids and asymptomatic, with a 3 month or greater interval since last dose of brain irradiation, and no evidence of progression * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: * AST or ALT no greater than 4 times ULN Cardiovascular: * Adequate cardiac function * LVEF at least 50% predicted or lower limit of normal Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent medical or psychological condition that would preclude study compliance * No history of hypersensitivity to anthracyclines, eggs, or egg products PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior trastuzumab (Herceptin) allowed Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior antineoplastic therapy * No more than 1 prior systemic cytotoxic regimen for locally advanced, metastatic, or inflammatory breast cancer * No prior anthracyclines greater than 240 mg/m2 * No other concurrent antineoplastic agents * No concurrent treatment with other liposomal products other than doxorubicin HCl liposome Endocrine therapy: * See Disease Characteristics * At least 3 weeks since prior hormonal agents * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics Surgery: * Not specified Other: * At least 3 weeks since other prior investigational drugs
References
Publications (1)
- RESULTTheodoulou M, Batist G, Campos S, Winer E, Welles L, Hudis C. Phase I study of nonpegylated liposomal doxorubicin plus trastuzumab in patients with HER2-positive breast cancer. Clin Breast Cancer. 2009 May;9(2):101-7. doi: 10.3816/CBC.2009.n.019. PMID 19433391