etrozole versus Letrozole plus lapatinib (GW572016) in hormone-sensitive, HER-2 negative operable breast cancer. A double blind randomized phase II study with biomarker evaluation - LETLOB

Phase 1

• Conditions: HER-2 negative operable breast cancer; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2006-001907-13-GB
• Lead Sponsor: GlaxoSmithKline Research and Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-14
• Study Completion: 2011-04-09
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

Histologically confirmed infiltrating primary breast cancer of > 2.0 cm in size in largest clinical diameter; ER and/or PgR positive cancer (> 10% of positive cancer cell assessed by IHC); postmenopausal status; HER2 negative tumors (IHC 0-2+, or FISH negative); availability of tumor tissue suitable for biological and molecular examination before starting primary treatment; age over 18; ECOG PS 0-1; normal organ and marrow function; cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan; ability to understand and the willingness to sign a written informed consent document; ability to swallow and retain oral medication.
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

Stage IIIB, IIIC and inflammatory breast cancer; Stage IV breast cancer; contraindication to the treament with letrozole; prior treatment with chemotherapy, endocrine therapy and radiotherapy. Prior treatment with EGF targeting therapies; Treatment with any other investigational agents, or with all herbal (alternative) medicines; history of allergic reactions attributed to compounds of similar chemical or biological composition to lapatinib; uncontrolled inter-current illnesses; HIV-positive patients receiving combination anti-retroviral therapy; GI tract disease resulting in the inability to take oral medication; concomitant requirement for medication classified as CYP3A4 inducers or inhibitors

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified