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An Open Label Study to Assess the Effect of a Combination of Avastin and Docetaxel and Sequential Chemotherapy on Pathological Response in Patients With Primary Operable HER2 Negative Breast Cancer


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

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Trial Information

An Open Label Study to Assess the Effect of a Combination of Avastin and Docetaxel and Sequential Chemotherapy on Pathological Response in Patients With Primary Operable HER2 Negative Breast Cancer


Inclusion Criteria:



- female patients, >=18 years of age;

- primary HER2-negative operable breast cancer;

- tumor >2cm in size;

- ECOG performance status 0-1.

Exclusion Criteria:

- previous treatment for breast cancer;

- metastatic disease;

- current or recent (within 10 days of first dose of Avastin) use of aspirin
(>325mg/day) or full-dose anticoagulants for therapeutic purposes;

- clinically significant cardiovascular disease.

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:

Percentage of patients with pathological complete response in breast and lymph nodes

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Agencia Espanola del medicamento (AEM)

Study ID:

ML20382

NCT ID:

NCT00559754

Start Date:

December 2007

Completion Date:

September 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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