Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
Trial overview
Time to progression as evaluated by the investigator
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Time to progression as evaluated by the Independent Review Committee (IRC)
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Number of participants with tumor response as evaluated by the investigator
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Number of participants with tumor response as evaluated by the Independent Review Committee
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Percentage of participants with clinical benefit (CB) as assessed by the investigator
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Number of participants with a response of CR or PR by the indicated study week
Timeframe: Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72
Duration of Response (DOR)
Timeframe: From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)
Progression-Free Survival (PFS)
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Number of participants who progressed or died at or prior to 6 months, as a measure of six months progression-free survival (PFS)
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Overall Survival
Timeframe: Randomization until the date of death due to any cause (average of 24 months)
Change from Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores
Timeframe: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Change from Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Timeframe: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Change from Baseline in Trial Outcome Index (TOI) Questionnaire Scores
Timeframe: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Number of participants with the indicated ErbB2 status at Baseline
Timeframe: Baseline
ErbB2 ratio
Timeframe: Baseline
Number of participants with the indicated immunohistochemistry (IHC) results at Screening
Timeframe: Screening (Day -1)
Number of participants with the indicated ErbB2 fluorescence in situ hybridization (FISH) results
Timeframe: Baseline
Serum ErbB1 concentration
Timeframe: Screening (Day-1) and Withdrawal (up to Study Week 129)
Serum ErbB2 concentration
Timeframe: Screening (Day-1) and Withdrawal (up to Study Week 129)
Number of participants with the indicated adverse events (AEs) with a maximum toxicity grade of 3 or 4
Timeframe: Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks)
Participation criteria
- Inclusion criteria:
- Signed Informed Consent
- 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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.