None listed
Conditions
Brief summary
This study looks at the effectiveness of the drugs lapatinib and vinorelbine in treating breast cancer (HER2/neu positive type) which has spread to distant sites and has been previously treated. Who is it for? You can join this study if you are a woman with Her2-positive breast cancer which has spread to distant sites and has progressed after initial treatment with trastuzumab-based treatment followed by lapatinib-capecitabine. Trial details Participants will receive lapatinib (1250 mg orally once daily) continuously and vinorelbine (20 mg/m2 (intra venous) on Day 1 and Day 8, of a 21-day cycle. Treatment will continue until any major toxic symptoms occur, or the disease or symptoms progress. If the cancer fails to respond, the patient will stop the study treatment and enter into the Survival Follow Up, where the cancer will be managed at the investigator’s discretion. Regular tumour scans will be used to monitor the disease. Scans will be completed 6 weekly until week 24 and then every 12 weeks thereafter. Quality of Life questionnaire will be completed by the patient to evaluate their pain and pain-relief use during the treatment period. The best combination of drugs to use after HER2 positive breast cancer has progressed on lapatinib-capecitabine is not known. Vinorelbine and lapatinib both have activity for the treatment of breast cancer. The study aims to evaluate the effect of this combination of drugs on survival rates and quality of life. Throughout the study the safety of the patient will be continually reviewed by the study doctor (physical examination, vital signs, side effects assessment & regular safety blood tests). Cardiac safety will be monitored by serial multi-gated acquisition scan (MUGA) or Echocardiograph at weeks 12, 24 & 52. For the first 5 patients enrolled in the study the Data Safety Monitoring Committee will review all side effects experienced during the course of cycle 1 and 2. This is to ensure that this treatment combination does not cause unacceptable side effects in a group of patients who have already received several lines of anti-cancer treatment. Overall survival will be assessed by contacting the patients every 3 months during the Survival follow up part of the study.
Interventions
Subjects will receive lapatinib (Investigational product) 1250mg daily, orally continuously with vinorelbine (Non-Investigational product) 20mg/m2 intravenously over 6 minutes (IV) Day 1 and Day 8 every 3 weeks until disease progression
Sponsors
Breast Cancer Research Centre of WA
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Electrocardiogram (ECG) with QTc interval less than or equal to 480 msecs .
Exclusion criteria
Subjects meeting any of the following History of allergic or hypersensitivity reactions to either study drug (or related compounds) or their excipients. Females who are pregnant or continuing to breast-feed. Subjects who have received more than 2 different types of treatment with a Her2/neu targeted therapy for metastatic breast cancer Evidence of a significant medical illness, abnormal laboratory finding or adverse event from prior anti-cancer therapy that would, in the investigators judgment, make the subject inappropriate for this study . Any serious psychiatric disorder, dementia or altered mental status that would interfere with the subject’s safety or compliance to the study procedures. GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn’s, ulcerative colitis). Current active hepatic or biliary disease (with exception of subjects with Gilbert’s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) Active cardiac disease Concurrent therapy given to treat cancer including treatment with hormonal therapy, an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment. Neuropathy = grade 2 at baseline Subjects previously treated with any vinorelbine or capecitabine (other than with lapatinib) Subjects cannot have received any other chemotherapy agent concurrent with trastuzumab and the taxane apart from the inclusion of a platinum agent in the first HER2/neu targeted regimen used in the metastatic setting . Prior treatment with anthracyclines with a cumulative dose of doxorubicin > 400 mg/m2 or epirubicin >800mg /m2 or equivalent dose for other anthracyclines derivatives . Subjects who have concurrent active infections requiring IV antibiotics or non-healing wound.
Outcome results
None listed