Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003642

Trial Description

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Title

An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a
taxane, with or without additional chemotherapy, as first-line treatment in patients with
locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv
every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are
contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal
doxorubicin) may be used. The anticipated time on study treatment is until disease
progression, and the target sample size is 500+ individuals.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003642
  •   2012/05/08
  •   2007/03/16
  •   no
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Secondary IDs

  •   NCT00448591  (ClinicalTrials.gov)
  •   MO19391  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Drug: bevacizumab [Avastin]
  •   Drug: Taxane-based chemotherapy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
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Primary Outcome

- Incidence of AEs, and SAEs related to Avastin; time frame: Throughout study

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Secondary Outcome

- Duration of survival, time to disease progression; time frame: Event driven

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Austria
  •   Brazil
  •   Bulgaria
  •   Canada
  •   China
  •   Colombia
  •   Czech Republic
  •   Ecuador
  •   Egypt
  •   Estonia
  •   Finland
  •   France
  •   Germany
  •   Hong Kong
  •   Hungary
  •   Israel
  •   Italy
  •   Latvia
  •   Lebanon
  •   Lithuania
  •   Malaysia
  •   Mexico
  •   Morocco
  •   Netherlands
  •   Poland
  •   Portugal
  •   Russian Federation
  •   Saudi Arabia
  •   Slovakia
  •   Slovenia
  •   Spain
  •   Sweden
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2006/09/30
  •   2300
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- patients, >=18 years of age;

- HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic
disease; (HER-2 positive patients only if previously treated with Herceptin in the
adjuvant setting;

- candidates for chemotherapy.

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Exclusion Criteria

- previous chemotherapy for metastatic or locally recurrent breast cancer;

- concomitant hormonal therapy for metastatic or locally recurrent disease;

- concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2
positive disease;

- previous radiotherapy for treatment of metastatic disease;

- evidence of CNS metastases.

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Please reference Study ID Number: MO19391 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.