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Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study

NCT00553358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2021-09-21

Study results available
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Summary

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 intravenous (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/m\^2 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/m\^2 IV for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with 5-Fluorouracil Epirubicin Cyclophosphamide (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 one year.

Primary objective is to evaluate and compare the rate of pathological complete response (pCR) at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable breast cancer randomised to lapatinib followed by lapatinib plus paclitaxel versus trastuzumab followed by trastuzumab plus paclitaxel versus lapatinib in combination with trastuzumab followed by lapatinib, trastuzumab plus paclitaxel.

Conditions

  • Neoplasms, Breast

Interventions

DRUG

Lapatinib

Small molecule receptor tyrosine kinase inhibitor

BIOLOGICAL

Trastuzumab

Therapeutic Monoclonal Antibody

DRUG

Paclitaxel

antimicrotubule agent

Sponsors & Collaborators

  • Breast International Group

    collaborator OTHER

  • SOLTI Breast Cancer Research Group

    collaborator OTHER

  • Novartis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-05
Primary Completion
2010-05-27
Completion
2019-12-23

Countries

  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Lithuania
  • Norway
  • Pakistan
  • Peru
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00553358 on ClinicalTrials.gov