CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 121 enrolled
Drug / intervention
lapatinib +5 moredrug
Likely dose
Paclitaxel 80 mg/m² weekly for 12 weeks; lapatinib 750–1250 mg/day orally; trastuzumab 2 mg/kg weekly (after 4 mg/kg loading dose); fluorouracil 600 mg/m² IV day 1 every 3 weeks × 4 courses; epidoxorubicin 75 mg/m² IV day 1 every 3 weeks × 4 courses; cyclophosphamide 600 mg/m² IV day 1 every 3 weeks × 4 coursesAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed primary breast cancer >2.0 cm in largest clinical diameter
  • ✓HER2 positive by IHC 3+ or FISH+
  • ✓Age 18–65 years
  • ✓ECOG performance status 0–1
Key exclusion· 9
  • ✕Stage IIIB, IIIC, or inflammatory breast cancer
  • ✕Stage IV (metastatic) breast cancer
  • ✕Prior chemotherapy, endocrine therapy, radiotherapy, or EGFR-targeting therapies
  • ✕Contraindication to anthracycline, paclitaxel, and/or trastuzumab

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00429299
NCT00429299Phase 2Completed
CompareCT.gov

Chemotherapy Plus Lapatinib or Trastuzumab or Both in Her2+ Primary Breast Cancer. A Randomized Phase IIb Study With Biomarker Evaluation.

GlaxoSmithKline·interventional·Posted Jan 31, 2007·Updated Mar 22, 2016

In Brief

A Phase 2 clinical trial evaluating lapatinib, trastuzumab, and 4 other interventions for Neoplasms, Breast. Completed, enrolled 121 participants across 17 sites in 3 countries.

Detailed Summary

Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesGermany, Italy, Poland
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2007
Enrollment StartAug 1, 2006
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 19.4 years ago

Interventions

lapatinibdrug

Arm B 1250mg/d PO Arm C 750mg/d PO

trastuzumabbiological

First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins

paclitaxeldrug

80mg/sqm 1 hour infusion for 12 weeks

fluorouracildrug

600mg/sqm iv day 1 q21 days for four coursess

epidoxorubicindrug

75mg/sqm iv day 1 q21 days for four courses

cyclophosphamidedrug

600mg/sqm day 1 q21 days for four courses