Last updated: 11/03/2018 08:25:34
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Study of Lapatinib in Breast Cancer Patients with HER-2 non-amplified primary tumors and HER-2 positive or EGFR positive circulating tumor cells
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A phase II open label, multicenter study to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 positive circulating tumour cells or EGFR positive circulating tumor cells
Trial description: The underlying biology of the various patterns of metastasis observed in different tumour types remains unclear. The detection and characterization of circulating tumour cells in cancer patients has provided important new information about the progression of metastatic events. This information has important implications for cancer prognosis and therapy.This multicenter open-label study is designed as a two-stage three-outcome phase II trial. The aim is to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 or EGFR positive circulating tumour cells. Evaluation of HER-2 and EGFR status on circulating tumour cells will be performed by the means of the CellSearch equipment (Immunicon, Huntingdon Valley, PA, USA) and FISH method (PathVysion Kit -Abbott Laboratories).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Overall response rate (ORR) per Response Evaluation Criteria In Solid Tumours (RECIST) as a measure of efficacy of lapatinib in advanced breast cancer participants over 6 months
Timeframe: Approximately up to 6 months
Secondary outcomes:
Clinical benefit rate (CBR) as a combination of complete response (CR), partial response (PR), and stable disease for more than or equal to (>=) 24 weeks
Timeframe: Approximately up to 6 months
Number of participants with adverse events (AEs), serious adverse events (SAEs), and deaths
Timeframe: Approximately up to 6 months
Number of participants with abnormal clinical laboratory parameters over period
Timeframe: Screening (-28 days), Day 1 of each cycle up to discontinuation of death whichever occurs first
Number of participants with worst national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) grade for laboratory and non-laboratory toxicity
Timeframe: Screening (-28 days), Day 1 of each cycle up to discontinuation of death whichever occurs first
Number of participants with abnormal 12-lead electrocardiogram (ECG) and echocardiogram (ECHO or MUGA) over period
Timeframe: Screening (-28 days, Day 1, and Every 8 weeks up to 6 months/ discontinuation
Duration of response (DoR) and duration of Clinical Benefit (DoCB) over priod
Timeframe: Approximately up to 6 months
Time to Tumor Progression (TTP) over period
Timeframe: Approximately up to 6 months
Time to Best Response (TBR) over period
Timeframe: Approximately up to 6 months
Interventions:
Drug: LAPATINIB
Enrollment:
23
Observational study model:
Not applicable
Primary completion date:
2012-30-06
Time perspective:
Not applicable
Clinical publications:
Marta Pestrin, Silvia Bessi, Alessandro M. Minisini, Giovanna Masci, Stefano Cascinu, Alberto Ravaioli, Roberta Di Marsico, Carlo Tondini, Lucio Crinò, Justin Stebbing, Marc Buyse, Angelo Di Leo. Copy of Final results of a multicenter Phase II clinical trial evaluating the activity of single agent lapatinib in patients with HER2 negative metastatic breast cancer and HER2 positive circulating tumor cells. A proof-of-concept study. Breast Cancer Res Treat. 2012;134(1):283-9.
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
GSK
Study date(s)
June 2008 to November 2013
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Female patients at least 18 years old with HER-2 negative breast cancer.
- Patients must have evidence of HER-2 or EGFR positive circulating tumour cells in a peripheral blood sample taken at screening visit.
- Unstable medical conditions, pregnant or lactating women.
- Inability to provide informed consent.
Inclusion and exclusion criteria
Inclusion criteria:
- Female patients at least 18 years old with HER-2 negative breast cancer. -Patients must have evidence of HER-2 or EGFR positive circulating tumour cells in a peripheral blood sample taken at screening visit. -Patients must have measurable, metastatic disease and no brain metastasis requiring local therapy. -Other criteria include ECOG score 0 to 2, life expectancy > 12 weeks, baseline organ function at screening visit, -Previous treatment with anthracyclines and/or taxanes in the neo-adjuvant, adjuvant or advanced setting, and at least one line of treatment for metastatic disease.
Exclusion criteria:
- Unstable medical conditions, pregnant or lactating women. -Inability to provide informed consent. -Lack of physical integrity of the upper gastrointestinal (GI) tract. -Co-existing malignancy or malignancies within the last 5 years with the exception of basal cell carcinoma or in-situ carcinoma, concurrent anti-cancer therapies (chemo or hormonal therapy) or investigational drugs other than study drug. -Concurrent radiotherapy to the only target lesion or concurrent bisphosphonates if bone metastases are the only target lesions. -Previous treatment with anti HER-2 or anti-EGFR therapies. -Protocol specified treatment regimens that would be inappropriate for the management of the subject.
Trial location(s)
Location
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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.
Additional information about the trial
Additional information
Not applicable
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