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

July 13, 2020 updated by: Zhong-yu Yuan, Sun Yat-sen University

Sun Yat-sen University Cancer Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 36 months
The time from randomization to disease progression or death from any causes
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 9, 2015

Primary Completion (ACTUAL)

May 31, 2020

Study Completion (ACTUAL)

May 31, 2020

Study Registration Dates

First Submitted

February 8, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (ESTIMATE)

February 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HER2 Positive Breast Cancer

Clinical Trials on lapatinib and capecitabine or vinorelbine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe