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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT02362958
Collaborator
(none)
159
Enrollment
1
Location
1
Arm
64.7
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: lapatinib and capecitabine or vinorelbine
 Phase 2

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.

Study Design

Study Type:
Interventional
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 :
Jan 9, 2015
Actual Primary Completion Date :
May 31, 2020
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lapatinib and Capecitabine or Vinorelbine

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

Drug: lapatinib and capecitabine or vinorelbine
lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)
Other Names:
  • Tykerb; Xeloda;NVB

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [36 months]

      The time from randomization to disease progression or death from any causes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Zhong-Yu Yuan, M.D., Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhong-yu Yuan, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT02362958
    Other Study ID Numbers:
    • SYSUCC-005
    First Posted:
    Feb 13, 2015
    Last Update Posted:
    Jul 15, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Capecitabine
    Vinorelbine
    Lapatinib

    Study Results

    No Results Posted as of Jul 15, 2020