The Myocet/Lapatinib Study. ICORG 10-03, V5
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|ClinicalTrials.gov Identifier: NCT01495884|
Recruitment Status : Terminated (Slower than anticipated accrual)
First Posted : December 20, 2011
Last Update Posted : October 26, 2015
This study is a Phase I/II open label, multi-centre trial. Patients with HER2+ve metastatic breast cancer, following disease progression during, or after, treatment with trastuzumab and taxanes, will be treated with Lapatinib (Tyverb™ 500-1250 mg orally daily - depending on the maximum tolerated dose (MTD) determined in the Phase I part of the study) plus Myocet™, 50-60 mg/m2 i.v q3 weeks).
Within the Phase I part, doses are assigned at registration according to the dose escalation scheme.
The dose for the Phase II part of the trial will be based on the MTD established in the Phase I part of the study.
Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity of study therapy. Safety assessments will be performed every 3 weeks for the first 24 weeks. Efficacy assessments (radiological examination) will be performed on all patients every 8 weeks (± 7 days) for the first 24 weeks. Cardiotoxicity assessments will be performed at weeks 6 and 12. From week 24, safety, efficacy and cardiotoxicity assessments will be performed every 12 weeks and at the end of treatment (disease progression, unacceptable toxicity or patient withdraws consent).
|Condition or disease||Intervention/treatment||Phase|
|Her2 Positive Metastatic Breast Cancer||Drug: non-pegylated liposomal doxorubicon (Myocet™) Drug: Lapatinib (Tyverb™)||Phase 1 Phase 2|
- To determine the optimal dose for lapatinib plus Myocet™, in combination, in patients with HER2-positive metastatic breast cancer following disease progression during, or after, treatment with trastuzumab and taxanes (Phase I).
- To evaluate the 6 month progression-free survival of patients with HER2-positive metastatic breast cancer, following disease progression during, or after, treatment with trastuzumab and taxanes, who are treated with lapatinib plus Myocet™ (Phase II plus patients treated at MTD in Phase I).
- To evaluate the overall survival time, duration of progression -free survival, time to treatment failure, confirmed tumour response rate and duration of response in patients treated with this regimen (Phase II plus patients treated at MTD in Phase I).
- To assess the safety and tolerability of this regimen in these patients.
- To assess the incidence of cardiotoxicity in these patients treated with this regimen.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Lapatinib Plus Myocet TM in Patients With HER2+ve Metastatic Breast Cancer Following Disease Progression During, or After, Treatment With Trastuzumab and Taxanes|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|Experimental: Lapatinib (Tyverb™) and (Myocet™)||Drug: non-pegylated liposomal doxorubicon (Myocet™) Drug: Lapatinib (Tyverb™)|
- Optimal dose for lapatinib plus myocet [ Time Frame: 6 months ]Determination of the optimal dose for lapatinib plus Myocet™, in combination, in patients with HER2-positive metastatic breast cancer following disease progression during, or after, treatment with trastuzumab and taxanes as measured by MTD (Phase I)
- Overall survival [ Time Frame: From registration to death ]overall survival time (OS - time from registration to death from any cause) as assessed by standard RECIST criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495884
|Bon Secours Hospital|
|Cork University Hospital|
|Mater Misercordiae University Hospital|
|Mater Private Hospital|
|St James's Hospital|
|St. Vincent's University Hospital|
|University Hospital Galway|
|University Hospital Limerick|
|Waterford Regional Hospital|