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A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in HER2 Negative Metastatic Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in HER2 Negative Metastatic Breast Cancer


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Locally recurrent or metastatic breast cancer

- No prior treatment for metastatic or locally recurrent disease

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

- History or clinical evidence of brain metastases

- Pregnancy

- Uncontrolled hypertension ( systolic > 150 mmHg and/or diastolic > 100 mmHg) or
clinically significant (i.e. active) cardiovascular disease

- Major surgical procedure or significant traumatic injury within 28 days prior to
enrolment

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression-free survival

Outcome Time Frame:

approximately 2.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Croatia: Ministry of Health

Study ID:

ML25312

NCT ID:

NCT01661153

Start Date:

March 2011

Completion Date:

October 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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