COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Neoadjuvant Herceptin in Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133796
Recruitment Status : Terminated (Closed to accrual 4/19/2006 / Study doesn't qualify for reporting.)
First Posted : August 24, 2005
Last Update Posted : February 7, 2017
Genentech, Inc.
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center

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
BREAST CANCER Drug: Herceptin 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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 : October 2001
Actual Primary Completion Date : September 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Heceptin
Herceptin administered to enrolled subjects
Drug: Herceptin
Other Name: Trastuzumab

Primary Outcome Measures :
  1. The effects of Herceptin and its efficacy in women with HER-2 overexpressing advanced breast cancer [ Time Frame: 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 [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133796

Layout table for location information
United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mothaffar Rimawi
Genentech, Inc.
Layout table for investigator information
Principal Investigator: Mothaffar Rimawi, MD Baylor Breast Center, Baylor College of Medicine

Layout table for additonal information
Responsible Party: Mothaffar Rimawi, Medical Director, Baylor Breast Care Center Identifier: NCT00133796    
Other Study ID Numbers: H-10379
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:
Breast Cancer
Advanced Breast Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents