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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-09

Study Completion Date

2020-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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HER2 Positive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lapatinib and Capecitabine or Vinorelbine

Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8)

Group Type EXPERIMENTAL

lapatinib and capecitabine or vinorelbine

Intervention Type DRUG

lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)

Interventions

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lapatinib and capecitabine or vinorelbine

lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)

Intervention Type DRUG

Other Intervention Names

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Tykerb; Xeloda;NVB

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No