A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Capecitabine; Lapatinib; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Metastatic breast cancer

• Eastern Cooperative Oncology Group (ECOG) 0 or 1

• HER2-expressing primary or metastatic tumor

• Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.

• Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

• Normal organ function, including bone marrow function, renal function, liver function, and cardiac function

• Signed and dated an informed consent form

• Life expectancy of at least 12 weeks

Exclusion Criteria:

• Pregnant or breast feeding

• left ventricular ejection fraction (LVEF) < 45% by echocardiogram

• Disease-free interval (DFI) less than 12 months

• Uncontrolled medical problems

• Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin

• Patients were unable or unwilling to comply with program requirements