Know Cancer

or
forgot password

An Open Label Neoadjuvant Study to Assess the Effect of Avastin on Tumor Response in Patients With Inflammatory or Locally Advanced Breast Cancer


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

Thank you

Trial Information

An Open Label Neoadjuvant Study to Assess the Effect of Avastin on Tumor Response in Patients With Inflammatory or Locally Advanced Breast Cancer


Inclusion Criteria:



- female patients, >=18 years of age;

- stage III, or inflammatory breast cancer;

- ER/PgR positive or negative and HER-2 negative;

- normal LVEF.

Exclusion Criteria:

- previous chemotherapy/endocrine therapy;

- evidence of distant metastatic disease;

- other primary tumors in last 5 years (except for adequately treated cancer in situ of
the cervix, or basal cell skin cancer);

- chronic daily treatment with >325mg/day aspirin, or >75mg/day clopidogrel.

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:

Italy: Ministry of Health

Study ID:

ML19884

NCT ID:

NCT00559845

Start Date:

February 2008

Completion Date:

September 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location