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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer

Thank you

Trial Information

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer


Inclusion Criteria:



- Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the
breast, with measurable or non-measurable locally recurrent or metastatic disease.
Locally recurrent disease must not be amenable to resection with curative intent.

- ECOG performance status of 0 or 1

- For women of childbearing potential, use of an acceptable and effective method of
non-hormonal contraception

- For patients who have received recent radiotherapy, recovery prior to randomization
from any significant acute toxicity, and radiation treatments have to be completed
more than 3 weeks from randomization

Exclusion Criteria:

Disease-Specific Exclusions:

- HER2-positive status

- Prior chemotherapy for locally recurrent or metastatic disease

- Prior hormonal therapy < 2 weeks prior to randomization

- Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has
been for at least 12 months prior to randomization

- Investigational therapy within 28 days of randomization

General Medical Exclusions:

- Life expectancy of < 12 weeks

- Inadequate organ function

- Uncontrolled serious medical or psychiatric illness

- Active infection requiring intravenous (IV) antibiotics at screening

- Pregnancy or lactation

- History of other malignancies within 5 years prior to screening, except for tumors
with a negligible risk for metastasis or death

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival based on investigator tumor assessment in the intent-to-treat patient population

Outcome Time Frame:

approximately 47 months

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:

GO25632

NCT ID:

NCT01663727

Start Date:

August 2012

Completion Date:

July 2018

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Indianapolis, Indiana  
Charleston, South Carolina  
Honolulu, Hawaii  96813
Charleston, West Virginia  25304
Washington, District of Columbia  
Jackson, Mississippi