Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer

Sponsor
West German Study Group
Study ID
NCT01891357
Phase
PHASE2
Status
Terminated

Conditions

  • Carcinoma, Ductal, Breast

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Biopsy before and after three weeks of study treatment — PROCEDURE
    Core biopsies for histological analyses, to be analysed by the central pathology
  • paclitaxel — DRUG
  • lapatinib — DRUG
  • trastuzumab — DRUG

Study Details

The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer. The only treatment arm consists of Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks.

Key Dates

Start date
Sep 30, 2013
Status verified
Sep 2019
Primary completion
Nov 16, 2016
Completion
Nov 16, 2016

Study Design

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

Arms

  • Experimental: Paclitaxel + Lapatinib + Trastuzumab
    Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment

Primary Outcome Measure

Pathological Complete Response (pCR) [ Time Frame: Average of 16 weeks ]

Related Studies