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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02362958
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : September 27, 2018
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University

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
HER2 Positive Breast Cancer 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sun Yat-sen University Cancer Center
Actual Study Start Date : February 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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 Name: Tykerb; Xeloda;NVB

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 36 months ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02362958

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Contact: Zhong-Yu Yuan, M.D. 86-20-87343794

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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Zhong-Yu Yuan, M.D.    86-20-87343794      
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Zhong-Yu Yuan, M.D. Sun Yat-sen University

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Responsible Party: Zhong-yu Yuan, Professor, Sun Yat-sen University Identifier: NCT02362958     History of Changes
Other Study ID Numbers: SYSUCC-005
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators