GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

NCT00320411 | Completed Phase 2 Results

• 1 other identifier: EGF104911
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 8

Brief Summary

This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.

Conditions

Neoplasms, Breast

Keywords

Stage IV breast cancer; Herceptin; metastatic breast cancer; ErbB1; ErbB2; trastuzumab; lapatinib

Outcome Measures

Primary Outcomes (1)

• Overall Tumor Response

  Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.

  Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.

Secondary Outcomes (17)

• Duration of Response

  First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.

• Time to Progression

  Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.

• Clinical Benefit

  Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.

• Time to Response

  Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.

• 4-month Progression Free Survival

  Baseline to Month 4 (Week 16)

Study Arms (1)

Lapatinb

EXPERIMENTAL

Lapatinib 1500mg QD

Drug: lapatinib

Interventions

lapatinib DRUG

Lapatinib 1500mg QD

Lapatinb

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Life expectancy of ≥16 weeks from the start of lapatinib therapy;
• Signed informed consent obtained from the patient;
• Subjects must have histologically confirmed breast cancer with advanced (Stage IIIb, IIIc with T4 lesion) or metastatic disease (including recurrent patients);
• Subjects must meet the following criteria regarding prior therapy:
• Anthracyclines, taxanes:
• If anthracycline- and taxane-containing regimens are administered sequentially;
• Subjects should have been provided with at least 2 cycles each and at least 4 cycles in total.
• If anthracycline- and taxane-containing regimen are administered concurrently;
• Subjects should have been provided with at least 4 cycles in total. or
• Subjects should have been provided with at least 2 cycles in total and provided progressive disease occurred.
• If anthracycline- and taxane-containing regimen are administered separately;
• Subjects should have been provided with at least 4 cycles each. or
• Subjects should have been provided with at least 2 cycles each and provided progressive disease occurred each regimen.
• Trastuzumab:
• Prior treatment must contain trastuzumab alone or in combination with other chemotherapy for at least 6 weeks of standard doses.

You may not qualify if:

• Pregnant or lactating females;
• Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
• History of other malignancy. Subjects who have been disease free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
• Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety \* \[\* ≥Grade 3 (according to NCI-CTCAE Version 3.0), as a general rule\];
• Active or uncontrolled infection;
• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
• Known history of or clinical evidence of leptomeningeal carcinomatosis;
• Participated in a clinical study within the past 28 days of the first dose of lapatinib;
• Prior therapy with an ErbB1inhibitor (e.g., gefinitib) and/or ErbB2 inhibitor other than trastuzumab;
• Has taken/received prohibited inhibitors (including foods) of CYP3A4 within 7 days prior to the first dose of study medication or has taken/received prohibited inducers inducers (including foods) of CYP3A4 within 14 days prior to the first dose of study medication(Refer to Appendix 7).
• The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients
• Patients ineligible for participation in the study in the judgment of the investigator/sub investigator.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Ehime, 791-0280, Japan

Location

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Kanagawa, 241-0815, Japan

Location

GSK Investigational Site

Okayama, 701-0192, Japan

Location

GSK Investigational Site

Tochigi, 329-0498, Japan

Location

GSK Investigational Site

Tokyo, 104-0045, Japan

Location

GSK Investigational Site

Tokyo, 113-8677, Japan

Location

GSK Investigational Site

Tokyo, 135-8550, Japan

Location

GSK Investigational Site

Location

Related Publications (1)

• Toi M, Iwata H, Fujiwara Y, Ito Y, Nakamura S, Tokuda Y, Taguchi T, Rai Y, Aogi K, Arai T, Watanabe J, Wakamatsu T, Katsura K, Ellis CE, Gagnon RC, Allen KE, Sasaki Y, Takashima S. Lapatinib monotherapy in patients with relapsed, advanced, or metastatic breast cancer: efficacy, safety, and biomarker results from Japanese patients phase II studies. Br J Cancer. 2009 Nov 17;101(10):1676-82. doi: 10.1038/sj.bjc.6605343. Epub 2009 Oct 20.

  PMID: 19844234 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: November 28, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 31, 2019
• Results First Posted: December 14, 2009

Record last verified: 2018-08

Locations

JP (8)