A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer

Sponsor
Cancer Trials Ireland
Study ID
NCT01526369
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab — DRUG
  • Paclitaxel — DRUG
  • Lapatinib — DRUG

Study Details

The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples.

Key Dates

Start date
Feb 13, 2012
Status verified
May 2025
Primary completion
Nov 30, 2015
Completion
Feb 17, 2023

Study Design

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

Arms

  • Active Comparator: Paclitaxel and Trastuzumab
    Weekly paclitaxel (80mg/m², for 3 weeks of a 4 week cycle) + trastuzumab (8mg/kg loading dose on cycle 1 day 1 and 4mg/kg every 2 weeks) until disease progression, unacceptable toxicity or consent withdrawal.
  • Experimental: Paclitaxel, Trastuzumab and Lapatinib
    Weekly paclitaxel (80 mg/m², for 3 weeks of a 4 week cycle) + trastuzumab (8 mg/kg loading dose on cycle 1 day 1 and 4 mg/kg every 2 weeks) \+ lapatinib (1,000 mg daily), until disease progression, unacceptable toxicity or consent withdrawal.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 9 months ]

Related Studies