Clinical trial · Interventional
Lapatinib and Doxorubicin Hydrochloride Liposome in Treating Patients With Metastatic Breast Cancer
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of Lapatinib in Combination With Liposomal Doxorubicin in Patients With 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: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with doxorubicin hydrochloride liposome may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of doxorubicin hydrochloride liposome when given together with lapatinib in treating patients with 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 |
|---|---|---|---|
| Doxil | Drug | Doxorubicin | ALIAS |
| lapatinib ditosylate | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lapatinib Ditosylate and Doxil
- interventionNames
- Drug: lapatinib ditosylate
- Drug: Doxil
Primary outcomes (2)
- measure
- Cardiac safety
- timeFrame
- Throughout treatment and up to 30 days post-treatment
- measure
- Maximum tolerated dose
- timeFrame
- After the first cycle of therapy
Secondary outcomes (2)
- measure
- Pharmacokinetic profiles
- timeFrame
- After treatment completion for 12 patients treated at the maximum tolerated dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast with evidence of metastatic disease * Epidermal growth factor receptor (EGFR) and/or erbB2 positivity not required * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques OR as ≥ 10 mm by spiral CT scan * No known brain metastases or leptomeningeal disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female patients * Menopausal status not specified * Life expectancy ≥ 12 weeks * ECOG performance status 0-1 * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin normal * AST/ALT ≤ 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance ≥ 60 mL/min * LVEF ≥ 50% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow and retain oral medication * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib * No gastrointestinal (GI) tract disease resulting in inability to take oral medication * No malabsorption syndrome or requirement for IV alimentation * No uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis) PRIOR CONCURRENT THERAPY: * Prior trastuzumab (Herceptin ®) allowed * Prior anthracyclines allowed provided total dose of doxorubicin hydrochloride ≤ 240 mg/m² or epirubicin ≤ 600 mg/m² * More than 4 weeks since prior major surgery, hormonal therapy (other than replacement therapy), chemotherapy (6 weeks for nitrosoureas or mitomycin C), or radiotherapy and recovered * No prior surgical procedures affecting absorption * No prior EGFR-targeting therapies * At least 7 days since prior and no concurrent CYP3A4 inhibitors * At least 7 days since prior and no concurrent gastric pH modifiers * Antacids allowed within 1 hour before and after lapatinib dosing * At least 14 days since prior and no concurrent CYP3A4 inducers, including dexamethasone or dexamethasone equivalent dose \> 1.5 mg/day * At least 6 months since prior and no concurrent amiodarone * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent prophylactic growth factor support * No concurrent herbal medications * No other concurrent investigational agents or anticancer therapy
References
Publications (0)
Data not yet available