Chemotherapy plus Lapatinib (GW572016) or Trastuzumab or both in HER2+ Primary Breast Cancer. A Randomized Phase IIb study with Biomarker Evaluation - CHERLOB

Phase 1

• Conditions: HER2+ Primary Breast Cancer; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2006-001839-21-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: 2011-06-21
• 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 largest clinical diameter;
HER2 positive tumor (either IHC 3+ or FISH+);
Availability of tumour tissue suitable for biological and molecular examination before starting primary treatment;
Age > 18, < 65;
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;
Adequate contraception methods for women of child-bearing potential;
Ability to understand and 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) no
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 treatment with antracycline, paclitaxel and/or trastuzumab;
Prior treatment with chemotherapy, endocrine therapy or radiotherapy, Prior treatment with EGFR targeting therapies;
Treatment with any other investigational agents or herbal (alternative) medicines;
History of allergic reactions attributed to compounds of similar chemical or biological composition to lapatinib;
Uncontrolled intercurrent illness;
Pregnancy or breastfeeding;
Women of childbearing potential that refuse to adopt adequate contraceptive measures;
HIV-positive patient receiving combination antiretroviral therapy;
GI tract disease;
Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors;

Study & Design

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