A Randomized Phase IIb Study With Biomarker Evaluation (Cherlob) To Evaluate The Activity Of Different Combinations Of Lapatinib With Other Pre-Surgery Chemotherapy In Her2 Positive Operable Breast Cancer

Conditions: HER2+ Primary Breast Cancer
MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2006-001839-21-DE

Lead Sponsor: GlaxoSmithKline Reseacrh and Development Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 120

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;
Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of the use by the Principial Investigator.
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 121
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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;