Clincosm LogoSign in Get a demo

Neoadjuvant Herceptin in Patients With Breast Cancer

Sponsor
Mothaffar Rimawi (Other)
Overall Status
Terminated
CT.gov ID
NCT00133796
Collaborator
Genentech, Inc. (Industry)
40
Enrollment
1
Location
1
Arm
66
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are to better understand how Herceptin causes tumors to become smaller and to find out how effective Herceptin, together with chemotherapy, is in treating advanced breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

We want to determine the effects of Herceptin and to determine its efficacy in women with HER-2 overexpressing advanced breast cancer. The end-points will include the comparison of an array of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin.

The other aim of this study would be to determine clinical response to therapy with Herceptin and Taxotere.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of the Effects of Herceptin in Patients With Locally Advanced HER-2/NEU Overexpressing Breast Cancer
Study Start Date :
Oct 1, 2001
Actual Primary Completion Date :
Sep 1, 2005
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Heceptin

Herceptin administered to enrolled subjects

Drug: Herceptin
IV
Other Names:
  • Trastuzumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The effects of Herceptin and its efficacy in women with HER-2 overexpressing advanced breast cancer [1 year]

      A comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin

    Secondary Outcome Measures

    1. To determine clinical response to therapy with Herceptin and Taxotere [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients must be female.

    • Informed consent must be signed.

    • Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.

    • Her2/neu overexpressing tumors defined as HercepTest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (FISH) positive.

    • Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.

    • Kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.

    • Performance status (World Health Organization [WHO] scale) < 2 and life expectancy > 6 months.

    • Age > 18.

    • No metastatic disease without concomitant primary breast cancer.

    • No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

    Exclusion Criteria:

    • Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.

    • Severe underlying chronic illness or disease.

    • Cardiomyopathy or baseline left ventricular ejection fraction (LVEF) < 50%.

    • Patients on other investigational drugs while on study.

    • Severe or uncontrolled hypertension defined as blood pressure (BP) > 180/100 on three separate occasions.

    • History of congestive heart failure.

    • History of coronary arterial disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baylor Breast Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Mothaffar Rimawi
    • Genentech, Inc.

    Investigators

    • Principal Investigator: Mothaffar Rimawi, MD, Baylor Breast Center, Baylor College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mothaffar Rimawi, Medical Director, Baylor Breast Care Center
    ClinicalTrials.gov Identifier:
    NCT00133796
    Other Study ID Numbers:
    • H-10379
    First Posted:
    Aug 24, 2005
    Last Update Posted:
    Feb 7, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Mothaffar Rimawi, Medical Director, Baylor Breast Care Center
    Breast Cancer
    Advanced Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Trastuzumab

    Study Results

    No Results Posted as of Feb 7, 2017