Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer

Sponsor
Prof Dirk Elling
Study ID
NCT01172223
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Myocet (Non-pegylated liposomal doxorubicin (NPLD)) — DRUG
    60 mg/m\^2 i.v. day 1 q3 weeks
  • Paclitaxel — DRUG
    175 mg/m\^2 i.v. day 1 q3 weeks
  • Lapatinib (GW572016, Tykerb) — DRUG
    750-1500 mg/d orally daily until the day of the definitive surgery

Study Details

Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with * Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m\^2 i.v. day 1 q3 weeks), * Paclitaxel (175 mg/m\^2 i.v. day 1 q3 weeks), and * Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor size \<25% after 4 courses measured by ultrasound or MR-mammography), or if the patient requested to be released.

Key Dates

Start date
Sep 30, 2007
Status verified
Oct 2016
Primary completion
Jan 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
81 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LAPADO
    Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m2 i.v. day 1 q3 weeks), Paclitaxel (175 mg/m2 i.v. day 1 q3 weeks), and Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery)

Primary Outcome Measure

Determine the optimal doses for NPLD, paclitaxel and lapatinib (phase I) [ Time Frame: every 3 weeks ]

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