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AN OPEN LABEL STUDY TO ASSESS THE EFFECT OF FIRST LINE TREATMENT WITH AVASTIN IN COMBINATION WITH PACLITAXEL AND GEMCITABINE IN PROGRESSION-FREE SURVIVAL IN PATIENTS WITH HER-2 NEGATIVE BREAST CANCER


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

AN OPEN LABEL STUDY TO ASSESS THE EFFECT OF FIRST LINE TREATMENT WITH AVASTIN IN COMBINATION WITH PACLITAXEL AND GEMCITABINE IN PROGRESSION-FREE SURVIVAL IN PATIENTS WITH HER-2 NEGATIVE BREAST CANCER


Inclusion Criteria:



- female patients, >=18 years of age;

- breast cancer, with measurable, locally recurrent or metastatic lesions, or patients
with bone metastasis only;

- HER2-negative disease;

- candidates for chemotherapy;

- ECOG PS of <=2;

Exclusion Criteria:

- previous chemotherapy for metastatic or locally advanced breast cancer;

- previous radiotherapy for treatment of metastatic breast cancer;

- any prior adjuvant treatment with anthracyclines completed <6 months prior to
enrolment;

- chronic daily treatment with corticosteroids (>=10mg/day) aspirin (>325mg/day) or
clopidogrel (>75mg/day);

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Event driven; tumor assessments every 3 cycles

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain:Agencia Espanola del Medicamento

Study ID:

ML21999

NCT ID:

NCT00846027

Start Date:

February 2009

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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