HER2 Positive Breast Cancer
Conditions
Brief summary
Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.
Detailed description
Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.
Interventions
DRUGlapatinib and capecitabine or vinorelbine
lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 36 months | The time from randomization to disease progression or death from any causes |
Countries
China
Outcome results
None listed