Safety and Efficacy of Lapatinib Plus Trastuzumab or Lapatinib Plus Capecitabine in Metastatic Breast Cancer

Sponsor
Berufsverband Niedergelassener Gynäkologischer Onkologen in Deutschland e.V.
Study ID
NCT01985893
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib plus trastuzumab — DRUG
    Comparison of the safety and efficacy of lapatinib plus trastuzumab and lapatinib plus capecitabine.

Study Details

The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival, tumour response and overall survival.

Key Dates

Start date
Sep 30, 2013
Status verified
Jan 2016
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Lapatinib plus trastuzumab
    Drug intervention: Lapatinib IMP, Trastuzumab on prescription. Lapatinib 1000 mg p.o. once daily for 21 days. Trastuzumab i.v. infusion 8 mg/kg loading dose; 6 mg/kg on Day 1 of each subsequent 3 weekly cycle.
  • Other: Lapatinib plus Capecitabine
    Drug intervention: Lapatinib and Capecitabine on prescription. Lapatinib 1250 mg p.o. once daily. Capecitabine 2000 mg/m2 p.o. in two divided doses on days 1 to 14 of a 21 day cycle.

Primary Outcome Measure

6 month progression-free-survival-rate (PFS6) [ Time Frame: 6 months - from the date of randomization ]

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