A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT02362958 |
Recruitment Status :
Completed
First Posted : February 13, 2015
Last Update Posted : July 15, 2020
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Condition or disease | Intervention/treatment | Phase |
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HER2 Positive Breast Cancer | Drug: lapatinib and capecitabine or vinorelbine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 159 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Sun Yat-sen University Cancer Center |
Actual Study Start Date : | January 9, 2015 |
Actual Primary Completion Date : | May 31, 2020 |
Actual Study Completion Date : | May 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Lapatinib and Capecitabine or Vinorelbine
Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8)
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Drug: lapatinib and capecitabine or vinorelbine
lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)
Other Name: Tykerb; Xeloda;NVB |
- progression-free survival [ Time Frame: 36 months ]The time from randomization to disease progression or death from any causes

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362958
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510080 |
Principal Investigator: | Zhong-Yu Yuan, M.D. | Sun Yat-sen University |
Responsible Party: | Zhong-yu Yuan, Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT02362958 |
Other Study ID Numbers: |
SYSUCC-005 |
First Posted: | February 13, 2015 Key Record Dates |
Last Update Posted: | July 15, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Capecitabine Vinorelbine Lapatinib Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Protein Kinase Inhibitors Enzyme Inhibitors |