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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00553358 |
Purpose
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer. Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg iv load followed by 2 mg/kg iv weekly, or lapatinib 1000 mg daily with trastuzumab 4 mg/kg iv load followed by 2 mg/kg iv weekly for a total of 6 weeks. After this biological window, patients on monotherapy arms will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m2 for a further 12 weeks, up to definitive surgery. In the combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab 2 mg/kg IV plus weekly paclitaxel 80mg/m2 IV for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with FEC followed by the same targeted therapy as in the biological window of the neoadjuvant setting for a further 34 weeks (in the combination arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total duration of the anti-HER2 therapy will be one year.
| Condition | Intervention | Phase |
|---|---|---|
|
Early Breast Cancer ErbB2+ |
Drug: Lapatinib Biological: Trastuzumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study A Randomised, Multicenter Open-Label Phase III Study of Neoadjuvant Lapatinib, Trastuzumab and Their Combination Plus Paclitaxel in Women With HER2/ErbB2 Positive Primary Breast Cancer |
| Estimated Enrollment: | 450 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | November 2019 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1 Lapatinib: Experimental
1500mg lapatinib for 6 weeks followed by lapatinib plus weekly paclitaxel for an additional 12 weeks.
|
Drug: Lapatinib
Small molecule receptor tyrosine kinase inhibitor
|
|
Arm 2 Trastuzumab: Active Comparator
4 mg/kg IV loading dose followed by 2 mg/kg IV weekly trastuzumab for 6 weeks., followed by 2 mg/kg trastuzumab plus weekly paclitaxel for an additional 12 weeks.
|
Biological: Trastuzumab
Therapeutic Monoclonal Antibody
|
|
Arm 3 Lapatinib plus Trastuzumab: Experimental
1000mg lapatinib plus 4 mg/kg IV loading dose followed by 2 mg/kg IV weekly trastuzumab for 6 weeks, followed by 750mg lapatinib plus 2 mg/kg IV weekly trastuzumab plus weekly paclitaxel (80 for an additional 12 weeks.
|
Drug: Lapatinib
Small molecule receptor tyrosine kinase inhibitor
Biological: Trastuzumab
Therapeutic Monoclonal Antibody
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Show 107 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | EGF106903, BIG 1-06 |
| Study First Received: | November 1, 2007 |
| Last Updated: | June 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00553358 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Lithuania: State Medicine Control Agency - Ministry of Health; Spain: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
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Early Breast Cancer Neoadjuvant Lapatinib |
|
Skin Diseases Breast Neoplasms Tyrosine Lapatinib Protein Kinase Inhibitors Antibodies, Monoclonal Oxymetazoline |
Antibodies Paclitaxel Phenylephrine Trastuzumab Breast Diseases Immunoglobulins |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Lapatinib Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Trastuzumab Breast Diseases |