A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early

Sponsor
Thomas Hatschek
Study ID
NCT00957125
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Epirubicin — DRUG
    75 mg/m2 i.v. infusion, 30 min, cycle day 1, cycles 1-6.
  • Docetaxel — DRUG
    75 mg/m2 i.v. infusion, 60 min, cycles day 1, cycle 1-6.
  • Bevacizumab — DRUG
    15 mg/kg, i.v. infusion, 90 min, cycle day 1, cycles 3-6 if PR or SD after cycle 2.

Study Details

Patients with localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases receive six cycles of chemotherapy with epirubicin and docetaxel. Treatment evaluations are performed after the second, fourth and sixth cycle. In case of SD/PR after the second course, bevacizumab is added to the combination for the remaining four courses. Besides standard response evaluation clinically and by mammography and ultrasound, several functional imaging techniques including MR, CT-PET and contrast-enhanced ultrasound are investigated. Fresh tumor tissue samples from the primary tumor are collected before start, after two courses and in connection with surgery. The aim of the trial is to detect biological factors and functional imaging techniques with the ability to predict response at an early stage of treatment.

Key Dates

First listed
Aug 12, 2009
Start date
Sep 30, 2008
Status verified
Sep 2016
Primary completion
Nov 30, 2011
Completion
Nov 30, 2016

Study Design

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

Arms

  • Experimental: Epirubicin Docetaxel Bevacizumab
    Epirubicin and docetaxel i.v. infusion q 3 weeks for 2 cycles. * If complete response this treatment continues for 4 cycles, totally 6 cycles. * If partial response or stable disease, epirubicin and docetaxel and bevacizumab i.v. infusion q 3 weeks for 4 cycles. * If progressive disease after the first 2 cycles individualized treatment.

Primary Outcome Measure

Evaluation of the sensitivity and of defined diagnostic and biological procedures to detect response/non-response to neoadjuvant treatment at an early point among patients with breast cancer. [ Time Frame: 6 weeks ]

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