A randomised phase II screening trial with functional imaging and patient reported toxicity sub-studies comparing Lapatinib plus capecitabine versus continued Trastuzumab plus capecitabine after local therapy in patients with ErbB2-positive metastatic breast cancer developing brain metastasis/es

eeds Teaching Hospitals NHS Trust (UK)0 sites30 target enrollmentMarch 25, 2011

Overview

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32600919/ results (added 22/07/2020)

Registry

who.int

Start Date

March 25, 2011

End Date

February 28, 2013

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

eeds Teaching Hospitals NHS Trust (UK)

•1\. Male or female aged greater than or equal to 18 years
•2\. Eastern Cooperative Oncology Group (ECOG) performance status 0 \- 2
•3\. Given written informed consent prior to any trial specific procedures
•4\. Expected survival greater than or equal to 12 weeks
•5\. Histologically or cytologically confirmed invasive breast cancer, with stage IV disease including newly diagnosed central nervous system (CNS) metastasis/es
•6\. ErbB2 overexpression in the invasive component of the primary or metastatic lesion as locally defined by:
•7\.1\. 3\+ staining by immunohistochemistry (IHC)
•7\.2\. 2\+ staining by IHC in conjunction with ErbB2 gene amplification by FISH
•7\.3\. ErbB2 gene amplification by FISH
•8\. Participants with a negative or equivocal overall result are not eligible for inclusion in the trial

•1\. Prior therapy with lapatinib or an ErbB2 inhibitor other than trastuzumab
•2\. Prior treatment with capecitabine
•3\. Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of cancer
•4\. Known dihydropyrimidine dehydrogenase (DPD) deficiency
•5\. Current active hepatic or biliary disease (with exception of participants with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
•6\. Pregnant or lactating females. Women of child\-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to trial entry and for the duration of the trial participation.
•7\. History of significant non\-breast malignancy (aside from non\-melanomatous skin cancer, carcinoma in situ of the uterine cervix, superficial bladder cancer treated with curative intent)
•8\. History of allergic reactions attributed to compounds of a similar chemical or biological composition as to lapatinib
•9\. Uncontrolled inter\-current illness including, but not limited to:
•9\.1\. Ongoing or active infection