Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
University of Washington
Study ID
NCT00733408
Phase
PHASE2
Status
Completed

Conditions

  • Estrogen Receptor-negative Breast Cancer
  • HER2-negative Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Triple-negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can prevent cancer growth by blocking the ability of cancer cells to grow and spread. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial evaluates a maintenance treatment with erlotinib and bevacizumab after Nab-paclitaxel and bevacizumab which may control cancer growth with biologic therapies.

Key Dates

First listed
Aug 13, 2008
Start date
Apr 23, 2008
Status verified
Nov 2018
Primary completion
Jul 5, 2017
Completion
Sep 28, 2017

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tx (chemo, MoAb, and enzyme inhibitor)
    INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years ]

Locations (17)

FacilityCityStateZIPSite coordinators
Anchorage Oncology CentreAnchorageAlaska99508-
Katmai Oncology GroupAnchorageAlaska99508-
Providence Alaska Medical CenterAnchorageAlaska99508-
Yuma Cancer CenterYumaArizona85364-
Saint Joseph Regional Medical CenterLewistonIdaho83501-
Bozeman Deaconess HospitalBozemanMontana59715-
Kalispell Regional Medical CenterKalispellMontana59901-
Bend Memorial ClinicBendOregon97701-
Kadlec Clinic Hematology and OncologyKennewickWashington99336-
Evergreen Hospital Medical CenterKirklandWashington98033-
Skagit Valley Hospital Regional Cancer Care CenterMount VernonWashington98273-
Group Health Cooperative, RedmondRedmondWashington98052-
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-
Olympic Medical Cancer Care CenterSequimWashington98384-
Spokane Valley Cancer Center-MayfairSpokaneWashington99208-
Multicare Medical Oncology HematologyTacomaWashington98405-
Wenatchee Valley Medical CenterWenatcheeWashington98801-

Find similar trials in Anchorage, AK

By research site
Anchorage Oncology Centre· Anchorage, AKKatmai Oncology Group· Anchorage, AKProvidence Alaska Medical Center· Anchorage, AKYuma Cancer Center· Yuma, AZSaint Joseph Regional Medical Center· Lewiston, IDBozeman Deaconess Hospital· Bozeman, MT

Related Studies