Clinical trial · Interventional
Lapatinib and Vinorelbine in Treating Women With HER2-Overexpressing Locally Advanced or Metastatic Breast Cancer
Phase I Study Evaluating the Combination of Lapatinib + Vinorelbine in Patients With Locally Advanced or Metastatic Breast Cancer Overexpressing HER2
- 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 vinorelbine, 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 vinorelbine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and vinorelbine in treating women with HER2-overexpressing locally advanced 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 |
|---|---|---|---|
| Lapatinib | Drug | Lapatinib | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lapatinib + vinorelbine
- description
- * starting with loading dose of lapatinib per os for 7 days * then, combining lapatinib (oral daily continuous) + vinorelbine (intravenous, day 1 and 8 every 3 weeks)
- interventionNames
- Drug: Lapatinib
- Drug: vinorelbine
Primary outcomes (1)
- measure
- Toxicity as assessed by NCI CTCAE v3.0
- timeFrame
- during the first cycle of treatment
Secondary outcomes (2)
- measure
- Pharmacokinetic interactions between vinorelbine ditartrate (oral or IV) and lapatinib ditosylate
- timeFrame
- during the first cycle of treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced breast cancer (metastatic or locally advanced) * Tumor overexpressing HER2 (HER2 3+ by IHC OR HER2 2+ by IHC and FISH positive) in samples from the primary and/or secondary tumor * Measurable or evaluable disease * Cancer is progressive after treatment with at least 1 line or, at most, 2 lines, of chemotherapy that included trastuzumab (Herceptin®) * Patients presenting with treated asymptomatic cerebral metastases or leptomeningeal metastases may be included if they are neurologically stable and have not received steroids or anticonvulsant treatment for at least 4 weeks before study entry PATIENT CHARACTERISTICS: Inclusion criteria: * Female * Menopausal status not specified * Patients must have an estimated survival of at least 3 months * WHO performance status (ECOG) 0-2 * Hemoglobin ≥ 9 g/dL * ANC ≥ 1,500/mm³ * Platelets ≥ 100,000/mm³ * Total bilirubin ≤ 2.5 mg/dL * ALT and AST ≤ 3 times upper limit of normal * Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 40 mL/min * LVEF ≥ 50% (echographic or isotopic method) * Potentially reproductive patients must agree to use an effective contraceptive method while on study treatment * Patients must be affiliated with a Social Security system Exclusion criteria: * Uncontrolled cardiac pathology * Dysphagia or inability to swallow the vinorelbine ditartrate soft capsules * Malabsorption syndrome or disease significantly affecting gastrointestinal function * Preexisting neuropathy (grade ≥ 2) * Pregnant women, women who are likely to become pregnant, or women who are breastfeeding * Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Individuals deprived of liberty Exclusion criteria: * Prior major resection of stomach or proximal bowel that could affect absorption of oral drugs * Prior vinorelbine
References
Publications (0)
Data not yet available