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An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy


Inclusion Criteria:



- adult females, >=18 years of age;

- inflammatory breast cancer;

- HER2-positive tumors;

- performance status 0-2.

Exclusion Criteria:

- metastases;

- previous treatment with chemotherapy, radiation therapy or hormone therapy for a
breast tumor;

- clinically significant cardiovascular disease, or history of thrombotic disorders.

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:

Rate of pathological complete response

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Study ID:

ML21531

NCT ID:

NCT00717405

Start Date:

October 2008

Completion Date:

September 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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