A Phase II Study of Neoadjuvant Trastuzumab+Docetaxel+NPLD+/-Bevacizumab in Her2-pos. Early Breast Cancer

Sponsor
Austrian Breast & Colorectal Cancer Study Group
Study ID
NCT01367028
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab, Docetaxel — DRUG
    6 cycles - Day1 (Day22 = Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v. Docetaxel: 100 mg/m2 by 60 min i.v. infusion
  • Trastuzumab, Docetaxel, Bevacizumab — DRUG
    6 cycles - Day1 (Day22 = Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v. Docetaxel: 100 mg/m2 by 60 min i.v. infusion Bevacizumab 15 mg/kg
  • Trastuzumab+Docetaxel+NPLD — DRUG
    6 cycles - Day1 (Day22=Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v. Docetaxel: 75 mg/m2 by 60 min IV infusion NPLD 50 mg/m2 by 60 min i.v. infusion
  • Trastuzumab+Docetaxel+NPLD+Bevacizumab — DRUG
    6 cycles - Day1 (Day22= Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v. Docetaxel: 75 mg/m2 by 60 min i.v. infusion NPLD: 50 mg/m2 by 60 min i.v. infusion; Bevacizumab 15 mg/kg

Study Details

Multicenter randomised phase II study of neoadjuvant therapy in HER2 positive early breast cancer. Primary aim is to evaluate the cardiac toxicity of the combined treatment (trastuzumab, docetaxel, bevacizumab, NPLD) in comparison to the standard therapy.

Key Dates

First listed
Jun 6, 2011
Start date
Jun 30, 2011
Status verified
May 2014
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

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

Arms

  • Other: A: Trastuzumab+Docetaxel
  • Experimental: B: Trastuzumab+Docetaxel+Bevacizumab
  • Experimental: C: Trastuzumab+Docetaxel+NPLD
  • Experimental: D: Trastuzumab+Docetaxel+NPLD+Bevacizumab

Primary Outcome Measure

Cardiac toxicity [ Time Frame: between day 1 of cycle 1 and day 28 after the day of final surgery ]

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