Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
Trial overview
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)
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)
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)
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)
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)
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)
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)
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)
Participation 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.
- 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
- 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
- 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.
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.