Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT00331630
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib ditosylate — DRUG
    Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • paclitaxel albumin-stabilized nanoparticle formulation — DRUG
    30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Study Details

RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane together with lapatinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I, stage II, or stage III breast cancer.

Key Dates

Start date
May 4, 2006
Status verified
Jan 2020
Primary completion
Nov 10, 2006
Completion
Aug 5, 2010

Study Design

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

Arms

  • Experimental: Treatment arm
    30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Clinical Response Rate (cRR) [ Time Frame: At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Hematology-Oncology Associates of IllinoisChicagoIllinois60611-
Northwestern University, Northwestern Medical Faculty FoundationChicagoIllinois60611-3013-
Midwest Center for Hematology/OncologyJolietIllinois60432-
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia FieldsIllinois60461-
Joe Arrington Cancer Research and Treatment CenterLubbockTexas79410-1894-

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Hematology-Oncology Associates of Illinois· Chicago, ILNorthwestern University, Northwestern Medical Faculty Foundation· Chicago, ILMidwest Center for Hematology/Oncology· Joliet, ILSaint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields· Olympia Fields, ILJoe Arrington Cancer Research and Treatment Center· Lubbock, TX

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