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An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer


Phase 4
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer


Inclusion Criteria:



- Women >=18 years of age

- HER2-negative metastatic breast cancer

- Previous adjuvant chemotherapy or hormonal treatment

- >=1 measurable target lesion

Exclusion Criteria:

- Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy
for advanced or metastatic cancer

- Radiation therapy within 4 weeks of study treatment start or insufficient recovery
from the effects of prior radiation therapy

- Central nervous system metastases

- Other malignancy within last 5 years, except cured basal cell carcinoma of skin and
carcinoma in situ of uterine cervix

- Serious concurrent infection

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:

Overall Survival

Outcome Description:

Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death

Outcome Time Frame:

approximately 505 days (Median Time to Death)

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

ML18527

NCT ID:

NCT00121836

Start Date:

June 2005

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Flint, Michigan  48532
McLean, Virginia  22101
Scarborough, Maine  04074
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Charlotte, North Carolina  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina  
Tulsa, Oklahoma  
Las Vegas, Nevada  89109