Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT00618657
Phase
PHASE2
Status
Completed

Conditions

  • Breast Cancer
  • HER2-negative Breast Cancer
  • HER2-positive Breast Cancer
  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Given IV
  • paclitaxel albumin-stabilized nanoparticle formulation — DRUG
    Given IV
  • bevacizumab — DRUG
    Given IV
  • trastuzumab — DRUG
    Given IV
  • magnetic resonance imaging — PROCEDURE
    Optional correlative studies
  • therapeutic conventional surgery — PROCEDURE
    Post-chemotherapy surgery for patients with a response or stable disease must take place no sooner than 21 days after last dose of Herceptin; and 40 days after last dose of bevacizumab to allow for normalization of blood counts

Study Details

This phase II is studying the side effects and how well carboplatin and paclitaxel albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab before surgery works in treating patients with stage I-III breast cancer. Drugs used in chemotherapy, such as carboplatin and 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 and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and monoclonal antibody therapy together before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Key Dates

First listed
Feb 20, 2008
Start date
Feb 29, 2008
Status verified
Feb 2024
Primary completion
Jul 31, 2021
Completion
Jul 31, 2021

Study Design

Enrollment
127 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (HER-2 positive)
    Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, carboplatin IV over 60 minutes, and trastuzumab IV over 90 minutes , then weekly over 30-60 minutes. Treatment repeats every week for 12 weeks in the absence of disease progression or unacceptable toxicity. In both arms, beginning 21-40 days later, patients undergo surgery.
  • Experimental: Arm II (HER-2 negative)
    Patients receive paclitaxel albumin-stabilized nanoparticle formulation and carboplatin as in Arm I. Patients also receive bevacizumab IV over 90 or 60 or 30 minutes once every two weeks for 5 doses in the absence of disease progression or unacceptable toxicity. In both arms, beginning 21-40 days later, patients undergo surgery.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-

Find similar trials in Orange, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Chao Family Comprehensive Cancer Center· Orange, CA

Related Studies