Study Comparing GW572016 And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00073528
First received: November 24, 2003
Last updated: April 16, 2015
Last verified: February 2015
  Purpose

This study will compare the efficacy and tolerability of GW572016 administered in combination with letrozole, versus letrozole and placebo, as treatment for hormone receptor-positive advanced or metastatic breast cancer.


Condition Intervention Phase
Neoplasms, Breast
Drug: Lapatinib (GW572016)
Drug: Letrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor-Positive Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Her3 as Assessed by the Investigator [ Time Frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

  • Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.


Secondary Outcome Measures:
  • Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

  • PFS in Participants in the ITT Population as Assessed by the Investigator [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.

  • Overall Survival in the HER2-Positive Population [ Time Frame: From date of randomization until date of death due to any cause, assessed up to 46 months ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from randomization until death due to any cause.

  • Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.

  • Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date.

  • Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.

  • Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator. [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.

  • Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator. [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.

  • Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.

  • Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.

  • Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.

  • Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.

  • Overall Survival in the ITT Population [ Time Frame: From date of randomization until date of death due to any cause, assessed up to 46 months ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from randomization until death due to any cause.

  • Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.

  • Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date.

  • Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.

  • Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.

  • Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.

  • Number of Participants With Evidence of Brain Metastases From the ITT Population [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.

  • TTP for Participants From the ITT Population as Assessed by the Investigator [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.

  • Number of Participants With the Indicated Adverse Events (AEs) Related to Study Treatment Reported in 10% or More Participants in Either Treatment Arm [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study treatment.

  • Number of Participants With the Indicated Serious Adverse Events (SAEs) Related to Study Drug Reported by More Than One Participant in Either Treatment Arm [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.

  • Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits [ Time Frame: Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit ] [ Designated as safety issue: No ]
    Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 [not at all] to 4 [very much]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B.

  • Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data [ Time Frame: Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit ] [ Designated as safety issue: No ]
    Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer.

  • Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data [ Time Frame: Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit ] [ Designated as safety issue: No ]
    FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life.

  • Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data [ Time Frame: Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit ] [ Designated as safety issue: No ]
    The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life.

  • Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID => 8 for the FACT-B score, and an MID =>6 for the FACT-G and TOI scores.

  • Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Clinical benefit: participants with CR, PR, or SD for =>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present.

  • Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =>6-month period.

  • Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD.

  • Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL experienced seroconversion.

  • Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive [ Time Frame: Up to 46 months ] [ Designated as safety issue: No ]
    Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (>15 ng/mL) on two consecutive occasions.

  • Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+).


Enrollment: 1286
Study Start Date: December 2003
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo plus letrozole
Placebo plus letrozoleA daily dose of randomized therapy ) taken approximately at the same time each day.
Drug: Letrozole
2.5 mg orally once a day
Other Names:
  • Lapatinib (GW572016)
  • Letrozole
Experimental: lapatinib plus letrozole
GW572016 and letrozole A daily dose of randomized therapy ) taken approximately at the same time each day.
Drug: Lapatinib (GW572016)
1500 mg orally once a day
Drug: Letrozole
2.5 mg orally once a day
Other Names:
  • Lapatinib (GW572016)
  • Letrozole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent;
  • Subjects must have histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery [Singletary, 2002];
  • Tumors that are ER+ and/or PgR+;
  • Subjects will be considered ER+ or PgR+ if any assay [cytochemical, immunochemical, immunohistochemistry (IHC), or radioimmunoassay] of primary or secondary tumor tissue is positive;
  • Post-menopausal female subjects =18 years of age;
  • ECOG Performance Status of 0 or 1;
  • Subjects must have archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2. Archived tumor tissue will also be used to confirm estrogen receptor (ER) and/or progesterone receptor (PgR) positivity. Results will not be used to determine subject eligibility for the study;
  • Adjuvant therapy with an aromatase inhibitor is allowed; however, treatment must have ended more than 1 year prior (>12 months) to the first dose of randomized therapy;
  • Adjuvant therapy with trastuzumab is allowed; however, treatment must have ended more than 1 year prior (>12 months) to the first dose of randomized therapy;
  • Subjects who received neo-adjuvant/adjuvant therapy and now present with newly relapsed advanced or metastatic disease are eligible; however, prior neo-adjuvant/adjuvant therapy is not required for study entry; 11. Subjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP, [Premarin]), at least 1 month (30 days) prior to receiving the first dose of randomized therapy;
  • Radiotherapy prior to initiation of randomized therapy is allowed to a limited area (e.g., palliative treatment for painful bone metastases), if it is not the sole site of disease. Subject must have completed treatment and recovered from all treatment related toxicities, in particular bone marrow suppression;
  • Able to swallow and retain oral medication;
  • Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (or MUGA scan if an echocardiogram cannot be performed or is inconclusive);
  • Subjects must complete all screening assessments as outlined in the protocol;
  • Adequate organ function

Exclusion Criteria:

  • Pre-menopausal, pregnant, or lactating;
  • Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;
  • Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted;
  • 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;
  • Subjects who have not recovered from toxicities related to prior adjuvant therapy (e.g., surgery, radiotherapy, chemotherapy, hormonal therapy, immunotherapy, biologic therapy, and investigational agents);
  • Subjects who have received anthracyclines in the neo-adjuvant and/or adjuvant setting, which exceeded the following doses: 360 mg/m2 of Doxorubicin, 720 mg/m2 of Epirubicin, and 72 mg/m2 of Mitoxantrone;
  • Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or the disease is considered by the investigator to be rapidly progressing or life threatening;
  • Active or uncontrolled infection;
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
  • Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
  • Known history of, or clinical evidence of, central nervous system (CNS) metastases or leptomeningeal carcinomatosis;
  • Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or tumor embolization) other than letrozole;
  • Concurrent treatment with an investigational agent or participation in another clinical trial;
  • Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (GW572016 or placebo);
  • The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to randomized therapy (GW572016 or placebo) or to excipients of randomized therapy (GW572016 or placebo); 18. Subject has known hypersensitivity to Femara or excipients of Femara
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073528

  Show 278 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00073528     History of Changes
Obsolete Identifiers: NCT00084968
Other Study ID Numbers: EGF30008
Study First Received: November 24, 2003
Results First Received: April 19, 2012
Last Updated: April 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
advanced breast cancer
breast cancer
metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Lapatinib
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 07, 2015