Newly diagnosed infammatory breast cancer (IBC)
Conditions
Sponsors
GlaxoSmithKline R&D Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed breast carcinoma with clinical diagnosis of IBC - Tumour that:- Cohort A - overexpresses ErbB2 (defined IHC 2+ or 3+, or FISH-positive) with or without expression of ErbB1 (by IHC), or Cohort B - expression of ErbB1 (defined as IHC +) without overexpression of ErbB2. ErbB1 and ErbB2 status must be documented prior to dosing. - Tumour that is accessible for multiple biopsies - Male or female at least 18 years of age - Female patients must either be of non-childbearing potential, or if of childbearing potential to have negative serum pregnancy test at screening and to agree to a protocol-specified method of contraception during participation in the study - Able to swallow and retain oral medication - ECOG performance status 0-2 - Have adequate bone marrow function, and renal and hepatic function - Have left ventricular ejection fraction greater than or equal to 50% based on ECHO or MUGA scan - Provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Received prior biological, cytotoxic or hormonal therapy for breast cancer - Female who is pregnant or lactating - Patient who has malabsorption syndrome, disease affecting GI function, or resection of the stomach or small bowel - Considered medically unfit by the investigator - Has known hypersensitivity reaction or idiosyncrasy to drugs chemically-related to the IMPs - Received treatment with any investigational drug in previous 4 weeks - Currently receiving amiodarone or within 6 months prior to screening - Currently receiving oral steroid treatment, or any other protocol-specified prohibited medication. Use of cimetidine and/or steroids is permitted when required as standard treatment for paclitaxel administration. - Had major surgery within previous 2 weeks - Has condition/s which will not permit compliance with the protocol - Has peripheral neuropathy >= Grade 2 - Has Class II-IV heart failure (by NYHA classification system) - Has a clinically significant ECG abnormality - Has inadequate venous access for protocol-related blood sampling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of pathologic response rate following 14 days of neoadjuvant daily treatment with lapatinib monotherapy, followed by 12 weeks of daily lapatinib in combination with weekly-administered paclitaxel, in patients with treatment-naive IBC whose tumours overexpress ErbB2 +/- ErbB1 receptor(s) (Cohort A) and in patients whose tumours express the ErbB1 receptor but do not overexpress ErbB2 (Cohort B).;Secondary Objective: - To assess objective response rate following 14 days of lapatinib monotherapy and 12 weeks of lapatinib combined with weekly-administered paclitaxel - Assess safety and tolerability of once-daily lapatinib with weekly paclitaxel - Investigate pharmacodynamic effects of study treatment on intracellular biomarkers - Assess the effects of study treatment on proteomic profile and blood levels of extracellular domains of the ErbB1 and ErbB2 receptors - Pharmacogenetic investigation/s;Primary end point(s): Determination of complete pathologic response rate (pCR) | — |
Countries
Spain, United Kingdom
Outcome results
None listed