Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
GlaxoSmithKline Breast International Group North Central Cancer Treatment Group National Cancer Institute (NCI) National Cancer Institute of Canada |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00490139 |
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Lapatinib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer |
Estimated Enrollment: | 8000 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Non-metastatic operable primary invasive adenocarcinoma of the breast fulfilling the following:
For design 1: Randomization must be performed no longer than 12 weeks from day 1 of the last chemotherapy cycle after obtaining a post-chemotherapy LVEF ≥ 50. Study treatment should start no more than 14 days after randomization For design 2: Randomization must be performed no longer than 6 weeks from day 1 of the last anthracycline-containing chemotherapy cycle after obtaining a post-anthracycline chemotherapy LVEF ≥ 50. Study treatment should start no more than 14 days after randomization and must be concurrent with paclitaxel.
Equivocal local results may be submitted for a final determination by the central laboratory.
Exclusion Criteria:
NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of breast cancer or melanoma, at any time, are excluded from this study.
NOTE: multifocal/multicentric tumours are permitted:
History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%); High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled); Angina pectoris requiring antianginal medication; Clinically significant valvular heart disease; Evidence of transmural infarction on ECG; Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg);
serum total bilirubin >2.0 x upper limit of normal (ULN); alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) >2.5 x ULN; alkaline phosphatase (ALP) > 2.5 x ULN; serum creatinine >2.0 x ULN; total white blood cell count (WBC) <2.5 x 10^9/L; absolute neutrophil count <1.5 x 10^9/L; platelets <100 x 10^9/L.
Principal Investigator: | GSK Clinical Trials, MD | BIG, NCCTG |
Study ID Numbers: | EGF106708, BIG 2-06/N063D/MAC13 |
Study First Received: | June 20, 2007 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00490139 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
Adjuvant Early stage breast cancer ErbB2-overexpressing |
Skin Diseases Trastuzumab Breast Neoplasms Lapatinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |