HER2/ErbB2 positive primary breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Lapatinib
INN of investigational material : Lapatinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigationa
Sponsors
Novartis Pharma K.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age>=18 years 2. Eastern Cooperative Oncology Group (ECOG) performance status==50. Study treatment must start no more than 14 days after randomisation. For Design 2: Randomisation 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 must start no more than 14 days after randomisation and must be concurrent with taxanes. For Design 2B: Randomisation must be performed no longer than 8 weeks from definitive surgery. Non-anthracycline platinum containing regimen (docetaxel and carboplatin) and study treatment must start concomitantly and no more than 14 days after randomisation.
Exclusion criteria
Exclusion criteria: 1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma; 2. Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated 1) basal and squamous cell carcinoma of the skin or 2) carcinoma in situ of the cervix. 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 invasive breast cancer or melanoma, at any time, are excluded from this study. 3. Any clinically staged T4 tumour, including inflammatory breast cancer; 4. Bilateral tumours;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy To compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus weekly trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week washout period followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety To evaluate the safety and tolerability | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed