Last updated: 11/03/2018 11:45:11
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 GSK Clinical Study Register is no longer maintained for this study.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.
Lapatinib plus Capecitabine versus Trastuzumab plus Capecitabine in ErbB2 (HER2) positive metastatic breast cancer.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib plus Capecitabine versus Trastuzumab plus Capecitabine in Patients with Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer
Trial description: This open label study is designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of participants with Central Nervous System (CNS) metastases (as assessed by independent review) as the site of first relapse
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 10 months)
Secondary outcomes:
Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in >=2 participants in either treatment arm
Timeframe: From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)
Time to first CNS progression, defined as the time from randomization until the date of documented CNS progression as the first site of relapse
Timeframe: From randomization until the date of documented CNS progression (average of 10 months)
Number of participants with qualitative and quantitative toxicities
Timeframe: From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)
Number of participants with CNS progression at any time
Timeframe: From the time of randomization until death due to any cause (average of 10 months)
Progression free survival (PFS), as assessed by the investigator
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 10 months)
Number of participants expressing glucocorticoid receptor, phosphatase and tensin homolog (PTEN), phosphatidylinositide 3-kinase (PI3K)/AKT, protein 53 (P53), insulin-like growth factor-1 (IGF-1), and genes involved in cell cycle regulation
Timeframe: Baseline
Duration of response
Timeframe: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 10 months)
Number of participants with clinical benefit (CB)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 10 months)
Number of participants with Overall Response (OR), as assessed by the investigator
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 10 months)
Overall survival
Timeframe: From randomization until death due to any cause (average of 10 months)
Interventions:
Drug: lapatinib
Drug: capecitabine
Drug: trastuzumab
Enrollment:
546
Observational study model:
Not applicable
Primary completion date:
2012-11-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Metastases, Brain
Product
lapatinib
Collaborators
Not applicable
Study date(s)
April 2009 to December 2016
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
none
- Females at least 18 years old;
- ECOG Performance Status 0-2;
- History and/or current evidence of CNS metastases. Baseline MRI scan by Independent Reviewer to confirm no brain mets;
- Concurrent treatment with an investigational agent or participation in another treatment clinical trial;
Inclusion and exclusion criteria
Inclusion criteria:
- Females at least 18 years old;
- ECOG Performance Status 0-2;
- Histologically or cytologically confirmed HER2-positive invasive breast cancer, with Stage IV disease;
- Prior treatment with taxanes or anthracyclines is required;
- Prior treatment with other chemotherapeutic agents, trastuzumab, endocrine and radiation therapy is permitted;
- Baseline LVEF ≥ 50% and not lower than the institutional lower limit of normal;
- Concurrent treatment with bisphosphonates is permitted, however treatment must be initiated prior to the first dose of study therapy;
- Able to swallow and retain oral medications;
- Women with potential to have children must be willing to practice acceptable methods of birth control during the study;
- Normal organ and marrow function.
Exclusion criteria:
- History and/or current evidence of CNS metastases. Baseline MRI scan by Independent Reviewer to confirm no brain mets;
- Concurrent treatment with an investigational agent or participation in another treatment clinical trial;
- Prior therapy with lapatinib or an ErbB2 inhibitor other than trastuzumab (including but not limited to trastuzumab-DM1 and neratinib) and capecitabine;
- Known DPD deficiency;
- Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy for treatment of cancer;
- History of allergic reactions attributed to compounds chemically related to lapatinib (quinazolines), capecitabine, fluorouracil or any excipients;
- Concomitant use of CYP3A4 inhibitors or inducers;
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel;
- History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication to gadolinium contrast and other known contraindication to MRI;
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the patient’s safety or compliance to study procedures;
- have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease);
- Any on-going toxicity from prior anti cancer therapy except alopecia;
- Active cardiac disease;
- Uncontrolled infection;
- History of other malignancy, unless curatively treated with no evidence of disease for at least 5 years, subjects with adequately treated DCIS or LCIS, adequately treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix are eligible;
- Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of protocol treatment;
- Pregnant or lactating females.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
2012-11-06
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
Participate in clinical trial
Access to clinical trial data by researchers
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