Clinical trial NCT00089999: Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
Official title: A Phase II, Open-Label, Randomized, Parallel-Group Multicenter Trial Comparing Two Schedules of GW572016 as First-Line Monotherapy in Patients With Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms, Breast
Keywords: lapatinib
advanced
metastatic breast cancer
GW572016
ErbB2
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-08-23
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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.

Primary outcomes:
measure: 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)
timeFrame: 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)
measure: Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: Time to Response, as Assessed by the IRC and Investigator
timeFrame: 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)
measure: Duration of Response (DoR), as Assessed by the IRC and Investigator
timeFrame: 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)
measure: Progression-free Survival, as Assessed by the IRC and Investigator
timeFrame: 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)
measure: Time to Treatment Failure, as Assessed by IRC and Investigator
timeFrame: 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)
measure: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
timeFrame: From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to study week 192)
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Pokfulam
country: Hong Kong
facility: GSK Investigational Site
city: Delhi
country: India
facility: GSK Investigational Site
city: Hyderabad, Andhra Pradesh
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Bandar Tun Razak, Cheras
country: Malaysia
facility: GSK Investigational Site
city: Kubang Kerian
country: Malaysia
facility: GSK Investigational Site
city: Tanjong Bungah
country: Malaysia
facility: GSK Investigational Site
city: Tanjong Bungah
country: Malaysia
facility: GSK Investigational Site
city: Ixtaltepec / Espinal
country: Mexico
facility: GSK Investigational Site
state: Oaxaca
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
city: Rawalpindi
country: Pakistan
facility: GSK Investigational Site
city: Callao
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Bydogoszcz
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.