Phase 3 Completed N=579 Randomized Double-blind Treatment

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Breast Cancer

Source: ClinicalTrials.gov NCT00075270 ↗

Enrolled (actual)

579

Serious AEs

28.7%

Results posted

Mar 2014

Primary outcomePrimary: Time to Progression as Evaluated by the Investigator — 29.0; 22.9 weeks — p=0.142

Summary

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Progression as Evaluated by the Investigator	29.0; 22.9	0.142
PRIMARY Time to Progression as Evaluated by the Independent Review Committee (IRC)	33.7; 26.1	0.094
SECONDARY Number of Participants With Tumor Response as Evaluated by the Investigator	14; 6; 88; 67	—
SECONDARY Number of Participants With Tumor Response as Evaluated by the Independent Review Committee	1; 1; 77; 53	—
SECONDARY Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator	40.5; 31.9	—
SECONDARY Number of Participants With a Response of CR or PR by the Indicated Study Week	3; 0; 83; 55; 86; 57	—
SECONDARY Duration of Response (DOR)	28.3; 27.1	—
SECONDARY Progression-Free Survival (PFS)	25.1; 22.6	—
SECONDARY Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS)	133; 153	—
SECONDARY Overall Survival	23.82; 20.17	—
SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores	-1.1; -2.3; 1.0; -1.3; 1.4; -2.0	—
SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores	-0.7; -1.3; 0.4; -0.2; 1.1; -1.7	—
SECONDARY Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores	-2.3; -2.6; -0.5; -2.7; -0.1; -2.9	—
SECONDARY Number of Participants With the Indicated ErbB2 Status at Baseline	52; 39; 199; 202; 40; 47	—
SECONDARY ErbB2 Ratio	2.23; 2.14	—
SECONDARY Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening	139; 139; 50; 51; 15; 22	—
SECONDARY Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results	45; 35; 175; 165; 71; 88	—
SECONDARY Serum ErbB1 Concentration	58.6; 59.5; 59.0; 61.5	—
SECONDARY Serum ErbB2 Concentration	37.67; 36.19; 37.31; 39.95	—
SECONDARY Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4	43; 4; 1; 0; 10; 15	—

Eligibility Criteria

Inclusion criteria

Signed Informed Consent
Able to swallow an oral medication
Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
Adequate kidney and liver function
Adequate bone marrow function
Tumor tissue available for testing
Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested

Exclusion criteria

Prior treatment regimens for advanced or metastatic breast cancer.
Pregnant or lactating
Conditions that would effect the absorption of an oral drug
Active infection
Brain metastases
Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
Known hypersensitivity to Taxol or excipients of Taxol
Peripheral neuropathy of Grade 2 or greater is not permitted
Severe Cardiovascular disease or cardiac disease requiring a device.
Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00075270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.