Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

NCT00089999 | Completed Phase 2 Results

• 1 other identifier: EGF20009
• Study Type: interventional
• Target: 138
• Locations: 11 countries
• Sites: 31

Brief Summary

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

Conditions

Neoplasms, Breast

Keywords

lapatinib; advanced; metastatic breast cancer; GW572016; ErbB2

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)

  OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of \>= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made \>=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.

  From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)

• Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator

  OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of \>= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made \>=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.

  From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)

Secondary Outcomes (6)

• Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator

  From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer (up to Study Week 103)

• Time to Response, as Assessed by the IRC and Investigator

  From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 103)

• Duration of Response (DoR), as Assessed by the IRC and Investigator

  From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 103)

• Progression-free Survival, as Assessed by the IRC and Investigator

  From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 103)

• Time to Treatment Failure, as Assessed by IRC and Investigator

  From randomization until the first documented sign of disease progression, death due to any cause, or early discontinuation from investigational product (up to Study Week 103)

Interventions

Lapatinib DRUG

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
• Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
• Adequate renal, hepatic and cardiac function

You may not qualify if:

• Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. \[Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
• Patients with active brain metastases
• Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (31)

GSK Investigational Site

Hollywood, Florida, 33021, United States

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500921, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 8380456, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Pokfulam, Hong Kong

Location

GSK Investigational Site

Delhi, 110085, India

Location

GSK Investigational Site

Hyderabad, Andhra Pradesh, 500482, India

Location

GSK Investigational Site

Pune, 411001, India

Location

GSK Investigational Site

Bandar Tun Razak, Cheras, 59100, Malaysia

Location

GSK Investigational Site

Kubang Kerian, 16150, Malaysia

Location

GSK Investigational Site

Tanjong Bungah, 10450, Malaysia

Location

GSK Investigational Site

Tanjong Bungah, 11200, Malaysia

Location

GSK Investigational Site

Ixtaltepec / Espinal, Oaxaca, 70140, Mexico

Location

GSK Investigational Site

Mérida, Yucatán, 97500, Mexico

Location

GSK Investigational Site

México, Mexico

Location

GSK Investigational Site

Karachi, 54000, Pakistan

Location

GSK Investigational Site

Karachi, 74800, Pakistan

Location

GSK Investigational Site

Karachi, Pakistan

Location

GSK Investigational Site

Lahore, Pakistan

Location

GSK Investigational Site

Rawalpindi, Pakistan

Location

GSK Investigational Site

Lima, Lima Province, Lima 11, Peru

Location

GSK Investigational Site

Lima, Lima Province, Lima 13, Peru

Location

GSK Investigational Site

Lima, Lima Province, Lima 34, Peru

Location

GSK Investigational Site

Callao, Callao 2, Peru

Location

GSK Investigational Site

Bydogoszcz, 85-796, Poland

Location

GSK Investigational Site

Krakow, 31-115, Poland

Location

GSK Investigational Site

Olsztyn, 10-228, Poland

Location

GSK Investigational Site

Singapore, 169610, Singapore

Location

GSK Investigational Site

Singapore, 258500, Singapore

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Taipei, 114, Taiwan

Location

Related Publications (1)

• Lipton A, Leitzel K, Ali SM, Carney W, Platek G, Steplewski K, Westlund R, Gagnon R, Martin AM, Maltzman J. Human epidermal growth factor receptor 2 (HER2) extracellular domain levels are associated with progression-free survival in patients with HER2-positive metastatic breast cancer receiving lapatinib monotherapy. Cancer. 2011 Nov 1;117(21):5013-20. doi: 10.1002/cncr.26101. Epub 2011 Mar 31.

  PMID: 21456017 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2004
• First Posted: August 23, 2004
• Study Start: June 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 28, 2017
• Results First Posted: August 29, 2014

Record last verified: 2017-01

Locations

MY (4); SG (2); TW (2); US (1); HK (1); CL (3); IN (3); PA (5); ME (3); PE (4); PL (3)