![]() |
|
![]() |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
GlaxoSmithKline Breast International Group Grupo Espanol de Estudio, Tratamiento y Otras Estrategias Experimentales en Tumores Solidos |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00553358 |
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 will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m2 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 neoadjuvant setting for a further 34 weeks. The planned total duration of the anti-HER2 therapy will be one year.
The primary objective of this study is to evaluate and compare the rate of pathological complete response at the time of surgery in patients randomised to receive neoadjuvant lapatinib or trastuzumab or their combination plus paclitaxel. Secondary objectives include the comparisons of safety and tolerability, objective tumour response rate, disease free survival and overall survival, conversion to breast conserving surgery and node negative disease at surgery among the three neoadjuvant treatment arms and the identification of molecular features of responding tumours.
Condition | Intervention | Phase |
Early Breast Cancer |
Drug: Lapatinib |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, 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: | November 2007 |
Estimated Study Completion Date: | September 2019 |
Estimated Primary Completion Date: | September 2019 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
![]() |
Show 221 Study Locations |
GlaxoSmithKline |
Breast International Group |
Grupo Espanol de Estudio, Tratamiento y Otras Estrategias Experimentales en Tumores Solidos |
Principal Investigator: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | EGF106903, BIG 1-06 |
First Received: | November 1, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00553358 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Ministry of Health; Lithuania: State Medicine Control Agency - Ministry of Health |
|
|
|
|
|
![]() |