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A Randomized, Phase II, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) And/Or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple Negative Breast Cancer


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

Thank you

Trial Information

A Randomized, Phase II, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) And/Or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple Negative Breast Cancer


Inclusion Criteria:



- Women age >/= 18 years

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Histologically confirmed ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma
of the breast

- Confirmed availability of tumor tissue

Exclusion Criteria:

- Prior therapy with two or more regimens for metastatic breast cancer

- Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1

- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days
prior to Day 1 of Cycle 1

- Prior therapy with a taxane for metastatic breast cancer

- Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative VEGF
pathway-targeted therapy following diagnosis of breast cancer

- Prior therapy with hormones and/or trastuzumab

- Inadequate hematology, renal, or hepatic organ function

Bevacizumab exclusion criteria

- Uncontrolled hypertension (systolic pressure > 150 mmHg and/or diastolic pressure >
100 mmHg), with or without anti-hypertensive medication

- Evidence of bleeding diathesis or coagulopathy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) or death on study from any cause

Outcome Time Frame:

Time from randomization to disease progression or relapse or death from any cause within 30 days of the last study treatment, whichever occurs first.

Safety Issue:

No

Principal Investigator

See-Chun Phan, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

OAM4861g

NCT ID:

NCT01186991

Start Date:

March 2011

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Albany, Georgia  31701
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Flint, Michigan  48532
Kansas City, Kansas  66160
Boston, Massachusetts  
Charlotte, North Carolina  
Charleston, South Carolina  
Las Vegas, Nevada  89109
Salt Lake City, Utah  84112