Lapatinib and Vinorelbine in Treating Women With HER2-Overexpressing Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Lapatinib; Vinblastine; Vinorelbine

Criteria

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